Dexacell s the addition of oral dexamethasone to usual care in patients who present to urgent and emergency care with cellulitis effective and cost-effective in terms of reducing pain, improving quality of life, and reducing further antibiotic usage and healthcare use?

Why is this an important question to answer?
Cellulitis is a common bacterial skin infection and has a major impact on patients and healthcare utilisation. Hospital treatment costs in England and Wales alone are estimated at £220 million per year (1). When patients with cellulitis attend hospital they are usually treated with antibiotics and painkillers (2). However, even with this treatment around 1 in 5 patients will later seek further treatment due to ongoing symptoms – most often this is due to pain. This can lead to additional doctors appointments, A&E visits and additional antibiotics (3). It is therefore important to look for other ways to reduce early symptoms in patients with cellulitis, particularly pain.

There is a type of anti-inflammatory medicine called ‘corticosteroids’ that are often given to reduce inflammation and pain, improving short-term symptoms in patients with other types of infection and many other conditions. They are not currently used for the treatment of cellulitis but small research studies suggest that the addition of oral corticosteroids to antibiotics reduces pain and other symptoms, without adverse effects (4-6). Because of this, some guideline bodies recommend corticosteroids in patients with cellulitis, while others suggest further trial data is needed. A definitive clinical trial is needed to establish the costs and benefits of giving corticosteroids to patients with cellulitis by assessing outcomes that matter to patients and the health service.

We are therefore running this large trial across multiple hospitals across England and Wales. We are aiming to recruit 450 patients to participate in the trial so that we can find out whether giving people with cellulitis a ‘corticosteroid’ called dexamethasone can:

• Reduce pain,
• Improve quality of life,
• Reduce additional healthcare appointments,
• Reduce the need for extra antibiotics and pain relief,
• Reduce costs.

PI: Dr Edd Carlton

Planned end date: 31st January 2026

Local ref: 5411

Our aim is to understand how best to investigate acute severe headaches, which are suggestive of a condition called subarachnoid haemorrhage (SAH). SAH is a potentially severe cause of headache in the UK and requires urgent identification and treatment. It is defined as the presence of blood within one of the layers of the brain. At its most serious, it can cause death and severe disability.

We want to understand the accuracy of CT brain scanning in the Emergency Department (ED) and how this accuracy changes with time.

We will collect data on patients presenting to the Emergency department that have headaches reaching peak intensity within one hour. These are the classic headache patterns that raise concern with clinicians about the possibility of SAH. We will use this data to try and validate recently proposed clinical rules, and CT brain strategies, which suggest they can exclude the possibility of SAH with a high degree of precision.

With this information, we will be able to inform clinicians how accurate CT brain scans are safely excluding SAH. Further to this, we will highlight how this accuracy changes depending on the timing of the scan, using hourly intervals from onset of the headache. We will also evaluate the accuracy of clinical decision rules (without any brain scans) to exclude the condition of SAH.

Project Details
Principal Investigator: TBC
Planned End Date: TBC
Local Ref: 4761

MUUTO Delphi Study: Establishing Best Practice in Managing Malignant Upper Urinary Tract Obstruction

The Bristol Urological Institute, in partnership with North Bristol NHS Trust, is leading a national Delphi consensus study to develop best practice standards for the management of Malignant Upper Urinary Tract Obstruction (MUUTO)—a complex condition affecting patients with advanced cancers.

MUUTO can lead to significant symptoms, infection risk, and impaired kidney function, yet currently there is no national guidance to inform treatment decisions. Management varies widely across the UK, often leaving clinicians and patients without clear direction—particularly in emergency settings. This study brings together around 40 expert clinicians from across urology, oncology, interventional radiology, palliative care, and specialist nursing. Using the Delphi method, which is an established process for building expert consensus, the study will run two survey rounds followed by a final discussion meeting to agree on clinical standards. Importantly, this work has been shaped by patients and carers. Prior research revealed many felt confused about their diagnosis and excluded from decision-making. Their insights have helped define the focus of this study, ensuring the guidance developed reflects real patient needs.

The final output will be a set of practical, consensus-based recommendations to guide MUUTO diagnosis, intervention decisions (e.g. stents or nephrostomy), and palliative care options. These will support clinicians in delivering more consistent, evidence-informed, and patient-centred care. The study is scheduled to run over six months in 2025. Results will be shared via peer-reviewed publications, professional networks, and national conferences.

For Participant information, please visit here.

Project Details:

Principal Investigator: Mr Jonathan Aning
Local Ref: 5775

ACCTUATE is a randomised control trial, comparing the newly designed CymActive catheter, with a standard Foley type, over a period of three months. 

The Foley catheter was designed in the 1930’s, and is still in common use today, despite having several major side effects, including high levels of infection and impaired quality of life. The ACCTUATE study seeks to establish the acceptability of a newly designed catheter, the CymActive. The Cymactive catheter differs from the foley in design and use. It is entirely indwelling, and activated using a magnet, rather than having tubes protruding from the body, and is anchored in place with a mallecot anchoring system rather than the standard water filled balloon used by the foley, allowing complete bladder emptying. 

The primary aim of this study is to measure patients quality of life and pain, using patient questionnaires. The study will also monitor adverse events, and compare urine samples from the beginning and end of the study. 

For this study we are recruiting men with long term foley catheters, no previous lower urinary tract surgeries, with non-neurogenic urinary retention, of any age. 

Project Details

Principle Investigator: Professor Hashim Hashim. 

Planned recruitment end date: October 2025

Local reference: 5516

Prospective, non-randomized, multicentre clinical evaluation of the recharge free Axonics SNM System (INS Model 4101)

Sacral Neuromodulation (SNM) is a recommended treatment for Overactive Bladder (OAB) including urinary urgency incontinence (UUI) and urinary frequency (UF), and fecal incontinence (FI). Long-term data support the safety, efficacy, and durability of the therapy. 

This study is a multi-centre non randomized, single arm trial, aiming to confirm that there are no new safety and performance outcomes for participants receiving the Axonics SNM System INS Model 4101 for the treatment of OAB and FI. 

INS Model 4101, also known as F15 is a non-rechargeable system, whereas previous Axonics neurostimulators use a rechargeable battery source that requires monthly recharging by the patient. The mechanism of action is identical to previous devices: therapy is delivered to the sacral nerve, typically the 3rd sacral nerve root. Model 4101 (F15) uses the same exact stimulation waveform as the previous Axonics models.

For this study, patients who are listed for SNM at Southmead, for OAB, will be offered the opportunity to participate, and followed up for a year after implantation, attending 3 monthly check ups and completing a series of questionnaires. 

Project Details

Principle Investigator: Professor Hashim Hashim

Planned recruitment end date: July 2025

Local Reference: 5668

A comparison of diagnostic accuracy of Luminal Index and Standard of Care MRI for Accelerated detection of significant prostate cancer 

This study is trying to establish if a scanning method called Luminal Index MRI (LI-MRI) might be able to be as good as the Standard of Care MRI (SOC-MRI). 

A LI-MRI scan takes only 5-10 minutes compared to up to 45 minutes needed for a SOC-MRI scan and it does not require the injection of dye to improve images. 

Most people that enter the study will have had a PSA (Prostate Specific Antigen) blood test with a higher-than-normal reading.

Routinely, the next step would be to have a SOC-MRI scan of the prostate to investigate. 

Participants to the trial will have both types of MRI, the usual SOC-MRI plus the new LI-MRI in the same scan session.

The purpose of the MRI is to produce an image that your doctor examines to look for anything of concern that needs to be investigated further. 

If there is, the doctor would usually take samples of prostate tissue (biopsies) using a needle that would then be examined under a microscope to see if what was seen on the MRI image was cancer or caused by something else. 

Project Details

Principal Investigator: Mr Douglas Kopcke and Mr Stefanos Bolomytis (Co-PI)

Planned Recruitment End Date: Summer 2026

Local Ref: 5598

A radical prostatectomy (surgical treatment for prostate cancer) involves removal of the entire prostate gland and, in some cases, removal of the nearby pelvic lymph nodes.

 Even though both types of surgery take place in the UK, we do not know which one is better for men.  About 30% of men in the UK have some lymph nodes removed during their surgery for prostate cancer and the rest do not. Your surgeon will always use their expertise to decide what treatment is best for you. In this situation they are unsure whether it is best to leave the lymph nodes in or to take them out. 

The ELIPSE study will help us find out which is the best treatment for men who need to have prostate cancer surgery in future.  The ELIPSE study aims to answer the question, 'In men having surgery for prostate cancer, is removing lymph nodes better than not removing them?' 

Participants will be randomly allocated to one of two groups: prostatectomy alone or prostatectomy plus lymph node dissection, then followed up with questionnaires and medical records review.

Project Details:

Principal Investigator: Mr Anthony Koupparis

Planned Recruitment End Date: August 2026

Local Ref: 5212

MoonRISe-1 is a clinical research study of an investigational drug delivery system for adults with intermediate-risk non-muscle invasive bladder cancer.

The MoonRISe-1 study is evaluating an investigational drug delivery system called TAR-210.

Study doctors want to learn more about the effects of TAR-210 when it delivers controlled doses of an investigational medication (erdafitinib) into the bladder over approximately 12 weeks.

The TAR-210 is a small, flexible tube that is inserted into the bladder by a healthcare professional using a urinary catheter.

TAR-210 is not approved for use by any regulatory authority and can only be used in research studies such as this one.

Suitability for this trial includes testing your bladder tumour for specific genetic alterations called fibroblast growth factor receptor (FGFR) alterations.

FGFR alterations can be a factor in tumour growth and whether the cancer spreads.

FGFR testing needs to be performed on a urine and/or tumour tissue sample collected at screening.

If your tumour has the required FGFR alterations, you may be eligible to participate in the MoonRISe-1 study.

If you are eligible for this study, you will be randomly assigned to either :

Group A: The investigational drug delivery system (TAR-210) OR:

Standard of Care Chemotherapy (intravesical Mitomycin C)

Project Details

Principal Investigator: Miss Helena Burden

Planned Recruitment End Date: Summer 2025 

Local Ref: 5531

Early stage prostate cancer can be managed by active surveillance, where patients are closely monitored. If the cancer reaches a certain stage (“progresses”) the patient can access curative treatment (such as surgery or radiotherapy). In the TAPS02 trial we are testing to see if we can slow down this chance of progression or maybe even stop it using short-term drug treatment.

The drug used is Apalutamide. It belongs to a group of drugs that work by blocking androgens (male hormones). By blocking the effect of androgens, apalutamide stops prostate cancer cells from growing and dividing. Doctors currently use apalutamide to treat men with non-metastatic castration-resistant prostate cancer (prostate cancer for which initial treatments have failed).

In the TAPS02 trial we are testing if short-term apalutamide might slow tumour growth and make it less likely for men on surveillance to progress and need treatment. Eligible participants are randomly selected to receive apalutamide or placebo and followed up accordingly with blood tests, health checks and imaging.

Project Details

Principal Investigator: Mr Jonathan Aning

Planned Recruitment End Date: Spring 2026

Local Ref: 5543

Background

Pelvic health or pelvic floor symptoms during pregnancy or after childbirth are more common than often recognised. Research evidence suggests that about one in three women will experience some form of urinary incontinence after childbirth, one in ten faecal incontinence, and one in 12 pelvic organ prolapse. More than two-thirds of women with postpartum urinary incontinence and more than a third of women with faecal incontinence will still report it 12 years later. Several studies suggest that pelvic floor dysfunction is significantly under-reported due to embarrassment, self-consciousness, or a belief that it is ‘normal’ after pregnancy. The impact on women’s lives can be devastating, affecting affect women’s ability to work, their sexual and social relationships, and post-natal mental health.

What is the aim?

To develop a new questionnaire to help identify symptoms that affect pelvic health during pregnancy or postpartum. This is to empower women to self-report and monitor symptoms affecting the bladder, bowel and vagina, such as incontinence, and prolapse issues.

Asking women to routinely complete this questionnaire at key times during pregnancy is expected to raise awareness and identification of these symptoms, and improve referrals to specialist services for treatment when needed.

What will the PPHSAT project do?

The questionnaire will be developed according to a rigorous process, involving consultations with women and healthcare professionals, before being quantitatively tested in the maternity pathway.

There will be three main sub-studies:

• Exploratory interviews with perinatal women to understand their experiences of pelvic health issues, and expectations of care. This is alongside consultations with healthcare professionals and the public, to understand their views on what the content of the tool should be.
• Interviews with perinatal women to user test and refine the resulting tool.
• Quantitative testing of the final tool to understand how well it performs in practice in the maternity pathway

How is the study funded?

This study is funded by NHS England & Improvement as part of the national Maternity Transformation programme.

Project Details

Co-chief investigator: Dr Alan Uren, North Bristol NHS Trust

Co-chief investigator: Prof Nikki Cotterill, University of the West of England

Planned end date: 20/03/2024

Outcomes in patients with high-risk prostate cancer who undergo radical prostatectomy (surgery which aims to remove the whole prostate, and the cancer cells inside it) as a primary therapy have not significantly improved with time. Early prostate cancer is highly responsive to hormonal blockade. Therefore, androgen (a steroid hormone) blockade prior to and after prostate surgery could decrease tumour burden, increase the likelihood of complete resection and improve objective outcomes such as metastasis-free survival (MFS – time without the cancer spreading) and overall survival (OS).

The purpose of this study is to determine whether 6 months of treatment with apalutamide (an antagonist of the androgen receptor), with or without abiraterone acetate and prednisone (AAP), and in combination with androgen deprivation therapy (ADT), improves the pathological complete response rate and MFS rates in patients with high risk localised prostate cancer that are indicated to undergo a radical prostatectomy, compared to patients receiving ADT and a placebo.

The study will consist of a screening period of up to 35 days, after which participants will be randomised (randomly selected) to receive either apalutamide (with or without AAP) and ADT or receive ADT and a placebo. Participants will then receive 6 months of treatment in 28 day treatment cycles, before undergoing a radical prostatectomy. They will then receive a further 6 months of treatment. Following the treatment phase, participants will enter a post treatment phase in which they will be followed up until death, the cancer spreads, they withdraw from the study or they are lost to follow-up.

Project Details
Principal Investigator: Mr Jonathan Aning
Planned End Date: 02/05/2023
Local Ref: 4398

End-stage kidney disease (ESKD) affects ~55,000 people in the UK, with ~7,000 newly affected people each year. It ranks among the most severe of the chronic non-communicable diseases. Morbidity is high, with dialysis patients in the UK admitted to hospital on average ~1.5-2.0 times per year and spending ~15 days in hospital per year. Quality of life on dialysis is also well below that of the general population. There is therefore an unmet and urgent need to improve ESKD patient treatment.

Renal replacement therapy (dialysis or transplantation) is necessary when patients become symptomatic of ESKD. Currently ~90% of dialysis patients are on some form of haemodialysis (HD) or haemodiafiltration (HDF). Although HD and HDF can be performed at home, the majority is performed in-centre.

Treating the 25,000 people on HD costs around £500m of NHS spending each year, with a further £75m spent on hospital admissions and £50m on transport to and from dialysis. Half of patients now starting dialysis are 65 years or older and less likely to be fit for kidney transplantation and in the general population this group is predicted to increase by 60% (from 10.3m to 16.9m) by 2035. While preventing ESKD in the first place should remain a priority, the optimal form of dialysis will remain highly relevant to the NHS.

This study aims to establish the effectiveness and cost-effectiveness of high-volume HDF compared with high-flux HD in adult patients with ESKD on maintenance thrice weekly in-centre HD. We will do this by running a randomised controlled trial using non-cancer mortality or hospital admission due a cardiovascular event or infection as our primary outcome.

For more information about this study, please visit the H4RT website.

Project Details
Principal Investigator: Dr Fergus Caskey
Planned End Date: 30/09/2025
Local Ref: 3859

When kidney function drops to 15% of normal, symptoms such as tiredness, loss of appetite and sickness usually develop. At this stage, dialysis or kidney transplantation is considered. Not all patients are suitable for a kidney transplant so the following treatment options may be being considered:

• To prepare for renal dialysis if things progress – this involves visiting the hospital for 4 hours of treatment 3 times a week, or flushing fluid in and out of the body through the abdomen 4 times a day every day at home.
• To have all supportive treatment and care, but not plan to start renal dialysis even if things progress – this focuses on controlling symptoms with medication and aims to minimise hospital clinic visits and admissions. 

Surprisingly, for people over 65 with other health problems, survival and quality of life seem to be similar with these options. As a result, doctors and nurses seem to give quite different advice to their patients and the treatment people choose depends a lot on which renal unit they attend. More evidence is needed, therefore, to help patients and their families make an informed decision about the right treatment for them.

 The Prepare study is a randomised controlled trial which aims to provide far better evidence to help patients and their families reach the best decision for them and influence NHS policy on care for this group of patients.

For more information about this study, please visit the Prepare for Kidney Care website.

Project Details
Principal Investigator: Dr Fergus Caskey
Planned Recruitment End Date: May 2024
Report findings to NIHR August 2025

Local Ref: 3858a

Vitamin D deficiency is common in kidney failure and is a strong predictor of death from cardiovascular disease, infections and cancer. Dialysis patients typically receive pre-activated vitamin D, since it used to be thought that only the kidneys activate vitamin D. However, this increases blood calcium concentrations and may paradoxically make vitamin D deficiency worse. International treatment guidelines now recommend that kidney patients receive inactive vitamin D (known as cholecalciferol), since we now know that every organ activates vitamin D as required, even in kidney failure. However, this approach has not yet been tested in a trial. We will test whether supplementation with cholecalciferol increases survival in UK dialysis patients.

We will randomly assign adult UK dialysis patients to cholecalciferol or standard care.

We will determine the number of deaths over time in the two groups, to establish whether cholecalciferol improves survival. Whether patients are alive or dead at the end of the study will be determined from the national deaths register. We will also measure any differences in survival free from cardiovascular events, infections and cancers, the three leading causes of death in those on dialysis. We will use questionnaires to compare the quality of life of those in the two groups.

Currently only 68% of patients survive 3 years or more on dialysis. Assuming that this will be the case in the control group, we would need to witness 2200 deaths during the study to determine with a sufficient degree of certainty whether cholecalciferol improves survival. We estimate that this would require the inclusion of 4200 patients, followed for a total study duration of approximately 7 years. Put differently, this trial is designed to detect whether cholecalciferol has a clinically relevant effect by saving 4 or more lives for every 100 patients treated.

Project Details
Principal Investigator: Dr James Bushnell
Planned End Date: 01/03/2023
Local Ref: 4021

A study to correlate the epidemiological and clinical features of Steroid Resistance Nephrotic Syndrome including FSGS (Focal Segmental GlomeruloSclerosis) in childhood and Adulthood, in the UK, with genotype and to develop biomarkers of disease activity post-transplant.

Project Details
Principal Investigator: Dr Simon Satchell
Planned End Date: 31/12/2021
Local Ref: 2854

The National Registry of Rare Kidney Diseases (RaDaR) is a research initiative by UK kidney specialists (the Renal Association and the UK Renal Registry). It is designed to gather information from patients who have rare kidney diseases. This will give a much better understanding of how these illnesses affect people. It will help to improve treatment and identify possible causes of these rare diseases.

As patient information is entered into the database, researchers will be able to analyse whether certain aspects of their condition (e.g. laboratory results or treatments) are associated with specific benefits or complications. By allowing the research team to link this data with that gathered from other clinical studies, researchers will also be able to study the long-term outcome of these rare conditions and any treatments they may receive.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 09/10/2024
Local Ref: 2962

Primary systemic vasculitidies (PSV), encompassing Anti-Neutrophil Cytoplasmic Antibody (ANCA) associated vasculitis and medium vessel vasculitis, are relatively uncommon diseases, but have a propensity for renal involvement and account for a significant number of patients with both acute and chronic kidney disease. The aetiology of PSV is unknown and current therapies are non-specific and associated with major side effects. Outcome data for such patients have comprised small cohort studies from single centres. Understanding the factors that influence disease outcome and the impact different therapies have outside of clinical trials can only be achieved using a larger number of patients, accrued from multiple different units.

We propose to establish the first pan-UK PSV dataset, which will collect regular returns regarding patient recruitment and outcome from all participating centres. This will facilitate investigation of disease associations, outcomes and demographic trends for the UK PSV population. We will test the hypothesis that disease incidence is increasing in Indo-Asians and why the outcome may be different among different ethnic groups, as well as investigating contemporary outcomes with modern immunosuppressive protocols. In addition, we will combine clinical phenotype with genetic studies. Specifically we will investigate genetic variation between ethnic groups by looking at variations in DNA sequences that can help to explain differences in disease susceptibility. These are investigated using many DNA specific markers, called single-nucleotide polymorphisms (SNPs) whose expression will be compared between patients from different ethnic groups.

Finally, we will be able to record the outcome of all patients treated with novel therapeutics, thus eliminating the significant reporting bias that exists. This will allow individual investigators to carry out particular projects mining the dataset.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 28/02/2022
Local Ref: 3724

Calciphylaxis is a rare condition which results in small arteries becoming calcified. This results in painful ulceration of the skin which in turn can result in infection and further damage to tissue. It is associated with a high mortality rate (60–80%).

Consequently, research into this area is important. The aims of this study are to determine the following:

• What is the natural history of the disease?
• What risk factors are associated with development and progression of calciphylaxis?
• Which treatments currently in clinical practice confer a favourable outcome?
• What are the underlying disease processes?

These aims will be achieved by collecting information on medications, clinical parameters, local laboratory tests, measuring specific proteins and molecules in blood and tissue as well as studying patient’s DNA profiles.

Project Details
Principal Investigator: Mrs Saira Risdale
Planned End Date: 01/09/2021
Local Ref: 2970

This application relates to Phase 2 of the UNPACK study. Phase 1 - a qualitative interview study - informed Phase 2: a discrete choice experiment. Phase 2 uses the same screening and recruitment processes as in Phase 1. This application covers piloting of the study at a single site. It is our intention to expand to more sites following an amendment. This application will be submitted to the Research Ethics Committee that reviewed Phase 1.

Individuals at risk of kidney failure must choose between transplantation, dialysis, and non-dialysis care (also known as ‘comprehensive conservative care’ - CCC). Older people are rarely medically suitable for transplantation and are more likely to choose CCC than younger people. This may be because they don’t want intrusive treatment and are willing to live shorter lives to avoid it. Dialysis is particularly burdensome for them, with marginal survival benefit. People close to them, such as family members, are also involved in decision-making, but may be less willing to consider reduced survival to avoid treatment burden.

The trade-offs that older UK patients and those close to them are prepared to make have never before been quantified. Phase 1 of the UNPACK study used qualitative interviews to identify they treatment attributes and outcomes important to older people with kidney disease and those close to them when deciding between dialysis or CCC.

The discrete choice experiment is a questionnaire based on hypothetical treatment scenarios that measures treatment preferences of older people at risk of kidney failure and those close to them. The process will quantify and compare the importance of the treatment attributes (location and frequency) and outcomes (quality and quantity of life) identified in Phase 1. The results of this process will be used to inform the development of kidney services that fit better with the preferences of individuals using them.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 31/10/2022
Local Ref: 4764

Researchers want to find out if the drug bardoxolone methyl can improve the disease ADPKD (autosomal dominant polycystic kidney disease).

Bardoxolone methyl is an investigational (experimental) drug that is being tested and is currently not approved by any regulatory agency for sale. It is a semi-synthetic (man-made) substance based on the scaffold of the natural product oleanolic acid. Bardoxolone methyl was shown to inhibit inflammation-mediated processes and to improve parameters of kidney function in multiple clinical studies.

In this study, bardoxolone methyl will be given to participants as a capsule (pill).

The study has two main purposes:

• To see if bardoxolone methyl pills are safe and well tolerated in patients with ADPKD
• To see if bardoxolone methyl pills improve the estimated glomerular filtration rate (eGFR), a measure of kidney function

The study plans to enrol approximately 300 patients with ADPKD who are between the age of 18 and 70 years at up to 100 global study centres.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 31/12/2021
Local Ref: 4870

The ALIGN clinical trial is looking into a new tablet and it’s effectiveness in treating IgA Nephropathy, a disease which affects the tiny filters in the kidneys and their ability to remove ‘waste’ from the body which can lead to End Stage Kidney Disease and the need for Dialysis. Atrasentan has been developed by Chinook Therapeutics and has previously shown positive results in over 5000 people with diabetic kidney disease. In this study the tablet is taken once a day for 2.5 years. The trial is placebo-controlled meaning there is a 50/50 chance of receiving the trial drug or an inactive placebo, and to reduce bias, neither participants or their Doctors will know which they receive. 

A dedicated study team of nurses and doctors will care for participants during their time on the study, in partnership with their usual kidney doctors, and will see the participants in clinic approx. every 12 weeks, after a few weekly visits initially.

IgA Nephropathy currently has no approved treatments other than generic blood-pressure control and doctors are excited about the prospect of a treatment to delay the progression of this disease.

Principal Investigator: Dr Albert Power

Planned End Date: March 2023

Internal Reference: 5160

Individuals on dialysis are at risk of developing heart problems such as heart attacks and heart failure as well as high blood pressure. There is an urgent need for treatments that reduce the risk of heart problems in patients that require dialysis. Spironolactone is a tablet that is approved in the UK and has been used for over 50 years to treat heart problems in patients that do not require dialysis. Spironolactone belongs to a class of medicines called mineralocorticoid receptor antagonists (MRAs) and works by blocking a hormone called aldosterone in the body that can damage the heart.

Although spironolactone is very effective in patients that do not require dialysis, it is not known if spironolactone is effective in dialysis patients. We hope that this study will help determine if spironolactone works in dialysis patients. The purpose of this study is to determine if taking spironolactone will reduce death or hospitalization for heart failure and to see if it is well tolerated in patients that require dialysis.

Eligible participants will be asked to take spironolactone for 7-14 weeks to make sure it is safe for them. This is done by checking potassium results on weeks 1,2,3 and 7.  In the next part of the study, the participant will either be assigned to take the spironolactone tablet or a placebo (a tablet with no active medication) once a day.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 31 Dec 2023
Local Ref: 4891

There is a great shortage of kidneys for transplantation. All kidneys from deceased donors carry risk to the recipient (risk of not working, or of disease transmission), but donor age is strongly associated with poor function and early failure of the kidney transplant. This is important, because the majority of the pool of potential UK deceased donors are now over 60 years old. Thus, if we can improve our identification of kidneys from older donors that are better ‘quality’, we can maximise numbers of transplants performed without compromising transplant outcomes.

The use of urgent kidney biopsy (analysis of a small portion under the microscope) to identify age-related damage has been reported to aid selection of those kidneys from older donors that are good enough ‘quality’ for transplantation. This approach has not been widely adopted in the UK, because the exact impact that the extra information provided by biopsy has on transplant numbers and on transplant outcomes is not clear, and its cost effectiveness remains unproven.

Our study will evaluate whether providing an urgent 24 hour National Biopsy Service increases the number and function of kidneys transplanted from donors aged over 60 years. The study is a national trial: every four months a randomly-chosen group of UK kidney transplant centres will be offered access to the National Biopsy Service (a ‘stepped-wedge cluster randomised trial’). By the end of the trial, all UK centres will have access, and we will then compare results for each centre from before and after the biopsy service was made available as well as evaluating the cost of providing the service. We anticipate that this comparison will show that biopsy availability increases the use of kidneys from elderly donors by about 10%, which equates to an additional 180 kidney transplants performed in the UK per year.

Project Details
Principal Investigator: Dr Samuel Turner
Planned End Date: 31/01/2022
Local Ref: 4119

Enroll-HD is a prospective observational multicentre multi-national cohort study to be conducted in multiple native languages. Study visits will take place yearly and may occur at the time of the participant’s routine clinical care visit, where possible. The goal of Enroll-HD is to build a large and rich database of clinical information and biospecimens that will serve as a basis for future studies aimed at developing tools and biomarkers for progression and prognosis, identifying clinically relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies.

Principal Investigator: Dr Elizabeth Couthard
Planned End Date: Open ended
Local Ref: 3553

Enroll-HD (study explained above) is also a clinical research platform that supports other HD studies. Anyone participating in Enroll-HD study who have been confirmed to have the HD gene expansion are invited to take part in HDClairity.

HDClarity is looking at the biomarker, Cerebrospinal fluid (CSF). A biomarker is a biological measure that captures what is happening in a cell or organism at that given moment. These play an important role in understanding biological processes and understanding relationships between environment exposure, human biology and disease. CSF is an extremely useful biosample since it directly surrounds the brain and so likely reflects what is happening there throughout the course of disease. HDClarity is an open-ended study (no set end date) with CSF collection encouraged every year.
 

Principal Investigator: Dr Elizabeth Couthard
Planned End Date: 01/04/2026
Local Ref: 3817

European project title European eHealth Care Model for Rare Neurodegenerative Diseases: Development of HD-specific outcome measures UK study title Development and validation of multilingual, multinational HD specific need-based quality of life assessment tools: HD value assessment study.

This study is for anyone who is HD gene positive or companions of an individual who is HD gene positive. The aim is to find out more about their wishes, needs and expectations about living with Huntington’s Disease. From this, a questionnaire will be developed that can assess the quality of life for other individuals impacted by HD, in other countries too. 

PI : Ms Natalie Rosewell

Planned end Date: 01/09/2023

Local Ref: 4950
 

Longitudinal Adaptive Study of Molecular Pathology and Neuronal Networks in Huntington’s Disease Gene Expansion Carriers (HDGECs) and Healthy Controls using Positron Emission Tomography and Multi-modal Magnetic Resonance Imaging

Anyone participating in Enroll-HD study who has been confirmed to have the HD gene expansion are invited to take part in iMarkHD.

The study will compare PET and MRI scan measurements at different stages of the disease, with healthy control participants. This will look for changes which may influence the development of symptoms and disease progression. It may also lead to the identification of disease progression markers that characterise and predict symptom development which may be used in the future as outcome measures
 

PI: Dr Elizabeth Coulthard

Planned end date: 30/09/2024

Local Ref: 5213

The purpose of Address 2 is to identify people newly diagnosed with type 1 diabetes who might be interested in taking part in research studies. It is an observational study, requiring one clinic visit for consent, vital signs, questionnaires and blood samples. 

The information collected from participants will be used to understand more about the development and progression of type 1 diabetes. It will also help find suitable trials of new treatments or other studies into diabetes that participants might want to take part in. When suitable trials or studies are identified the participant will be contacted to ask if they would be interested in taking part.   

To enter the study, you must have a new diagnosis of Type 1 diabetes within the last 6 months prior to enrolment and be over the age of 18.  

The target size for this study is 10,500 participants with a multi-centre geographical scope across England. 

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date: March 2026
Local Ref: 2969

Ascend Plus is a randomised, double-blind, parallel-group, placebo-controlled event driven trial designed to test the hypothesis that oral Semaglutide reduces cardiovascular events and other complications of diabetes in people with T2DM. The study will randomise approximately 20,000 people with T2DM in the UK and follow them during a scheduled treatment period with a median duration of approximately 5 years.    

Participants will be identified from centrally held routinely collected healthcare databases and invited to join the trial. There will be no physical site visits, and all interactions with participants will be conducted directly using innovative patient-centred web-based technology, supplemented by telephone, video call contact and mailed letters. Study treatment will be mailed to participants.  

Given that detailed information about tolerability, non-serious adverse events and laboratory data have been collected in previous oral Semaglutide trials, this trial will focus on collecting serious adverse events and study outcomes relevant to patients with T2DM. This will be both during the scheduled treatment period and for the subsequent 20 years’ long-term follow-up after the scheduled treatment period.  

With comprehensive data collection and large sample size, this trial expects to produce a reliable assessment of the long-term effects of adding oral Semaglutide therapy to standard of care in a broad population of people with T2DM.   

Project details: 

Principal Investigator:  Dr Kahal
Planned End Date:  
Local Ref: 5518 

For more information, please visit ASCEND PLUS – UK’s Clinical Study Registry

FORWARD 1 is a Phase 2b study to assess the efficacy, safety and tolerability of IMVT-1402 as a treatment in adult patients with Grave’s Disease.

Grave’s Disease is an autoimmune disease caused by thyroid-stimulating autoantibodies that activate the thyroid-stimulating hormone receptor (TSHR). These autoantibodies induce an increased release of thyroid hormone, resulting in hyperthyroidism. 

IMVT-1402 is currently being developed as a potential treatment for Grave’s Disease. 

This study is taking place at approximately 13 sites across the UK, and approximately 240 participants will be enrolled. 

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date:  
Local Ref: 5793

The purpose of this research study is to learn more about Nisotirostide (LY3457263), a possible new medicine for the treatment of type 2 diabetes (T2D). 

About 200 people will be in this study. 

The study aims to learn: 

• Whether Nisotirostide, in combination with Tirzepatide or Semaglutide can reduce levels of HbA1c (a test that measures your average sugar levels over the past 2 to 3 months) in participants with T2D.
• Whether Nisotirostide works better than a placebo (a placebo is an inactive or “pretend” study drug).
• What are the possible side effects of treatment with Nisotirostide. 

 The study will last for 40 weeks with regular clinic visits and blood tests whilst you are in the treatment period.  

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date:  February 2027
Local Ref: 5723 

For more information, please visit GFZD – Clinical trials.gov

Maritime 2 is a study to see if the medication Maridebart Cafraglutide (MariTide) is safe, can help to lower body weight, and can improve weight-related conditions for adults who live with obesity or are overweight, and who also have type 2 diabetes mellitus (T2DM). 

The study will look at the safety of MariTide and whether it is better than a placebo at helping to reduce body weight when used in addition to a low-calorie diet and regular exercise.  

This study is for people with diabetes who have obesity (BMI of 30 or above) or are overweight (BMI of 27 or above). 

Participants will be randomly assigned to one of 4 groups and injected with the study product or a placebo at day 1, week 2, week 4 and then once every 4 weeks for 68 weeks. The study will last for approximately 2 years.  

Project details: 

Principal Investigator: Dr Russell 
Planned End Date: August 2027 
Local Ref: 5683 

For more information, please visit MARITIME-2 Clinical Trials.gov

Redefine 1 is a Phase 3 study testing the efficacy and safety of combining Cagrilintide with Semaglutide, known as CagriSema. These medications support those with obesity or overweight to lose weight. Semaglutide is also known to help lower blood sugar levels. 

Approximately 3400 participants will take part in this study globally.

Project details:

Principal Investigator: Dr Georgina Russell

Planned End Date: October 2026

Local Ref: 5189

For more information, please visit REDEFINE 1 – Clinical Trials.gov

Redefine 3 is a phase 3 study testing a new medicine called CagriSema to see if it can be used to treat people with cardiovascular disease. Cagrilintide and Semaglutide are medicines that can help people lose weight. Semaglutide also helps lower blood sugar. CagriSema has both Cagrilintide and Semaglutide in it. 

The primary purpose of this study is to investigate the long-term cardiovascular safety of CagriSema in participants with established cardiovascular disease. The study will also investigate whether CagriSema can reduce the risk of having cardiovascular events (for example heart attack and stroke). The study will include people with overweight or obesity that may also have type 2 diabetes and/or chronic kidney disease. 

Approximately 7000 participants across the world will take part in this study. About 370 participants will take part in the UK. Study duration is expected to be up to approximately 4.5 years following randomisation of the first participant. 

Project details: 

Principal Investigator: Dr Hassan Kahal 

Planned End Date:  October 2027

Local Ref: 5480

For more information, please visit REDEFINE 3 – Clinical Trials.gov

Redefine 8 is a study looking into the long-term effect of CagriSema on weight loss in people with obesity. 

The purpose of the study is to compare the efficacy and safety of CagriSema with placebo as an adjunct to a reduced-calorie diet and increased physical activity in participants with obesity. The study will also investigate long-term maintenance of weight loss during one additional year of full dose (2.4 mg/2.4 mg) CagriSema compared with a slow tapering of CagriSema.

The 3-year treatment duration includes a 2-year main phase and 1-year open label extension phase. During the main phase, participants should be on the target dose (2.4 mg/2.4 mg) for 88 weeks, which is considered sufficient to achieve weight loss plateau and provide robust data for the assessment of weight loss, additional efficacy and safety parameters. The 1-year extension phase is designed to explore weight maintenance regimes and assess the dose reduction’s ability to maintain weight loss. 

Approximately 400 participants are expected to take part in this study. 

Project details: 

Principal Investigator: Dr Georgina Russell 

Planned End Date:  November 2028

Local Ref: 5652

For more information, please visit REDEFINE 8 – Clinical Trials.gov

Redefine 9 is a phase 3b study to see how well different doses of CagriSema help people with excess body weight lose weight. 

The purpose of the study is to investigate efficacy and tolerability of CagriSema 1.7 mg/1.7 mg and 1.0 mg/1.0 mg once-weekly as an adjunct to a reduced-calorie diet and increased physical activity, in participants with overweight or obesity. 

A maintenance dose of CagriSema 2.4 mg/2.4 mg once-weekly has been chosen for the phase 3 weight management development programme to provide maximal weight loss while ensuring safety and tolerability. However, different dosing options are needed for weight management medications to accommodate individual variations in response and tailor the treatment to everyone’s treatment goals. Lower maintenance doses may be more appropriate for patients who can reach their treatment target at a lower dose or for patients where the higher dose is not well tolerated. Overall, dosing flexibility promotes patient centricity and allows prescribers to titrate up or down, based on individual needs. 

This is a 68-week treatment period with a 6-week follow-up period. Approximately 300 participants will take part in the study. 

Project details: 

Principal Investigator: Dr Georgina Russell 

Planned End Date:  April 2026

Local Ref: 5553

Surmount is a Phase 3, international, randomized, double-blind, parallel group, event-driven study to investigate the reduction of morbidity and mortality with once weekly Tirzepatide treatment compared to placebo in adult participants living with obesity and CVD risk. 

Tirzepatide has the potential of demonstrating clinically meaningful improvements in outcomes associated with weight loss. The purpose of this study is to determine if Tirzepatide is better than placebo in reducing obesity related disease and death in adults living with obesity.  

The dose escalation treatment period is the first 24 weeks of the study. The maintenance treatment period duration depends on when the specified number of endpoint events for the final analysis occurs. If the maintenance treatment period extends beyond 264 weeks, participants will continue extended maintenance visits every 12 weeks until the study ends.  

The study will enrol approximately 15,000 participants with a 1:1 randomization ratio to placebo and Tirzepatide. 

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date: September 2027 
Local Ref: 5245 

Stratus is a randomised controlled trial studying the effects of the glucose-monitoring Freestyle Libre device. The Freestyle Libre is a flash glucose monitor and, similar to continuous glucose monitoring devices, has made glucose checks much easier with the ability to obtain a large number of glucose readings daily that is simply not possible with traditional self-monitoring of blood glucose.  

The Stratus study has 3 main aims: 

Aim 1: Study the effects of Freestyle Libre on health care contact, hospital admissions and mortality in individuals with type 2 diabetes who have suffered an episode of severe hypoglycaemia. 

Aim 2: Analyse the effects of Freestyle Libre on quality-of-Life measures in type 2 diabetes patients. 

Aim 3: Explore the role of Freestyle Libre as a substitute for laboratory HbA1c measurements. 

The study observes participants with type 2 diabetes who have been recently treated by ambulance staff for hypoglycaemia or who have attended the hospital with hypoglycaemia. It is a randomised study in which one group of participants will be returned to standard of care whilst the other group will receive regular input from a diabetes specialist over six months whilst using the Freestyle Libre device.  

The study involves 6 months active involvement (2 blood samples and regular questionnaires) followed by a further 18 months of remote review of participant’s electronic medical records. The groups will be studied to assess how many participants had significant health problems following their initial hypoglycaemia and whether there was any difference in blood tests and quality of life measures between the two groups.   

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date:  October 2026
Local Ref: 5307 

UK-EDI is a prospective, observational cohort study collecting bio samples and questionnaires / clinical data from individuals over 50 years of age, who are newly diagnosed with type 2 diabetes. 

Most cases of new-onset diabetes are due to lifestyle or genetic factors, but in a small subset of individuals newly diagnosed with diabetes (approximately 1 in 100 people (1%)), the diagnosis of diabetes is believed to be an early sign associated with the development of pancreatic cancer (which should be categorised as type 3c diabetes). 

The UK-EDI study will collect clinical data, quality of life data and biological samples from a large cohort of individuals with new-onset diabetes to help try to distinguish between type 2 and type 3c diabetes, identify early signs of pancreatic cancer and determine how cost-effective screening would be if it were possible. 

The study aims to have 1000 patients enrolled from across the UK. The duration of the study for each participant is 3 years, with 5 clinic appointments and one data base check at 36 months. 

Project details: 

Principal Investigator: Dr Georgina Russell 

Planned End Date: Recruiting until 30 June 2026

Local Ref: 5172

ROSIER stands for ‘Requirement for Surgical Intervention after ERCP.’ ERCP -Endoscopic Retrograde Cholangiopancreatography - is the procedure you have done to remove your gallstones from your bile duct. 

After gallstones are removed from their bile duct, some people have their gallbladder taken out and some people don’t. Usually, the surgeon decides what they think will be best for the patient. However, while surgeons use their best clinical judgement, there isn’t yet enough evidence about which treatment is best for patients. 

The ROSIER study is looking at whether it is best for patients to have their gallbladder taken out after treatment for gallstones. It is a randomised study, so those taking part will be allocated via a computer as to whether they receive gallbladder surgery or not following their ERCP. Information about the health of the participants will be collected from both the participants and their healthcare records. These results will then be compared to try and determine whether gallbladder surgery post-ERCP is the best option.   The study may take up to two years and the participants will be asked to complete questionnaires on their health every three months. The study aims to recruit a total of 1318 patients across the UK. 

Project details: 

Principal Investigator: Mr James Hopkins 

Planned End Date: August 2027 

Local Ref: 5731

For further information, please visit ROSIER – UK’s Clinical Study Registry

The profound improvement in glucose control after Roux-en-Y-gastric bypass (RYGB) has led to the recognition of the intestine as a major player in glucose regulation. The optimal length of each of the three limbs (alimentary, biliopancreatic and common) remains controversial. This is further complicated by the differences in total small intestinal length in humans (ranging between 3.5-10.5 meters).

Anatomical arrangements of RYGB results in three segments or 'limbs':

• Alimentary limb: Through which food enters the small intestine through a gastric pouch (the remnant of the stomach)
• Biliopancreatic limb: Includes the bypassed segments of the duodenum (first section of the small intestine) and proximal jejunum (second section) through which the biliopancreatic (bile acids from the gall bladder and pancreatic) secretions flow and
• Common limb: In which the food and biliopancreatic secretions mix.

Current evidence supports the hypothesis that a 'modified' RYGB with a long alimentary limb and short common limb may optimize glucose control. There have not been any clinical trials comparing 'modified' and 'standard' RYGB with glucose control as primary outcome.

In this study, we propose to recruit 80 patients with type 2 diabetes mellitus (DM) and obesity who are eligible for metabolic surgery and currently on the waiting list for bariatric surgery at North Bristol NHS Trust obesity service. Randomisation will take place intra-operatively in patients with a total small intestinal length < 5.5 meters. The surgeon will contact the randomiser who will make the allocation to either 'modified' or 'standard' RYGB before continuing with the surgery.

Participants will attend 5 visits in total (baseline, day 10, 3, 6 and 12 months post operatively) for anthropometric measurements, blood tests, urine pregnancy test, assessment of number of glucose lowering medications and adverse event profile.

Project Details
Principal Investigator: Dimitri Pournaras
Planned End Date: 01/06/2022
Local Ref: 5007

PASIPHY studies people who have had bariatric surgery at least 6 months ago and now experience low blood sugar levels after eating meals. This condition is called post-bariatric hypoglycaemia (PBH).

This is a double-blind randomised placebo-controlled dose-finding phase II study. Participants are given a study medication called Pasireotide and the purpose of the study is to see if this medication works to control blood sugar levels in people with PBH.

Participants will be given either Pasireotide or Placebo for 12 weeks as an injection. After this, participants will have the option to continue in the study for a further 36 weeks, but all participants during this second phase will be given Pasireotide.

This study will be conducted in about 36 clinical sites in 6 countries: Belgium, France, Italy, Spain, the United Kingdom and the United States. Approximately, 72 participants will participate in this study. 

Project details:

Principal Investigator: Mr Dimitri Pournaras
Planned End Date: February 2026
Local Ref: 5482
For more information, please visit: PASIPHY – Clinical Trials.gov

(Rebuilding StrEngth Together after bariatric surgery)

Reset is study aiming to understand people’s views, experiences and hopes for undertaking physical activity and strength exercise after bariatric surgery. The study involves talking to people who are on the waiting list for bariatric surgery or have undergone bariatric surgery. 

There are two phases – phase 1 involves completing a questionnaire, either online or on paper. Phase 2 involves taking part in interviews with a researcher to talk about your views and experiences in more detail. If you take part in phase 1 you do not need to take part in phase 2. 

Reset hopes to use the information from this study to plan how to offer people undergoing bariatric surgery more help with physical activity in the future. Physical activity programmes for people with obesity are not routinely offered in most NHS units at present and the Reset study aims to change this. 

This study is being conducted out of the University of Bristol alongside clinical researchers from Gloucestershire Hospitals NHS Foundation Trust. 

Project details: 

Principal Investigator: Mr Dimitri Pournaras 

Planned End Date: October 2026 

Local Ref: 5626

A groundbreaking research study exploring the potential of blood tests to diagnose dementia is underway at North Bristol NHS Trust, marking a significant step toward improving the UK’s dementia diagnosis rate.

This initiative, led by the READ-OUT (REAl World Dementia OUTcomes) research team at Dementias Platform UK (DPUK), seeks to address gaps in diagnosis and enhance early detection of dementia, ultimately improving outcomes for people living with the condition.

The study is part of the Blood Biomarker Challenge – a multi-million-pound programme led by Alzheimer’s Society and Alzheimer’s Research UK, supported with funds raised by players of People’s Postcode Lottery. It aims to explore whether a panel of blood tests can complement existing diagnostic pathways in NHS memory clinics, helping clinicians provide faster and more accurate diagnoses for people living with dementia.

The team will assess multiple new and existing blood tests, looking at a range of dementia types including Alzheimer’s disease, vascular dementia, frontotemporal dementia, and dementia with Lewy bodies. The researchers will also look at whether the blood tests can help detect these diseases at various stages and if the results need to be interpreted differently in people from different ethnic backgrounds or with other health conditions such as kidney disease.

The first participants joined the study in Oxford in January 2025, marking the start of a nationwide drive to recruit over 3,100 participants from currently 31 DPUK sites across the UK. These sites, located in NHS memory clinics and community buses, aim to recruit participants from a diverse range of communities, ensuring the research is inclusive and reflects the wider population.

This research will provide vital evidence needed to integrate blood tests into routine clinical practice in the NHS, ultimately improving diagnosis speed and accuracy, and ensuring that more people in Bristol and across the UK receive timely treatments and support.

For more information on READ-OUT or to register interest in taking part in the study, visit the READ-OUT study site.

PI: Professor Elizabeth Coulthard

Planned end date: 31/10/2029

Local Ref: R&D 5727

COmBining memantine and cholinesterase inhibitors in Lewy body dementia Treatment trial

The COBALT Trial aims to find out if adding Memantine to AChEI treatment improves overall health and functioning for people with Lewy Body Dementia (DLB) or Parkinson's Disease Dementia (PDD).
A 150 patients with DLB and 150 patients with PDD, from across the UK will  take part in this trial. Participation will consist of a few visits over 52 weeks to the site for cognitive assessments, telephone follow ups and monitored use of either the placebo or Memantine. 

PI Dr Elizabeth Coulthard

Recruitment end date:01 April 2025

Local Ref: R&D 5195

Our research group and others have found links between Alzheimer’s and gum disease. Gum disease occurs when certain bacteria thrive under the gum line causing inflammation and bleeding. There is good evidence these bacteria pass into the bloodstream and speed up, or cause development of other diseases (such as diabetes and heart disease). This study monitors Alzheimer’s patients treated for gum disease for 12 months to see if this also slows their rate of memory loss. We're looking for 50 participants. 

PI: Dr Elizabeth Coulthard

Planned end Date: May 2025

Local Ref: R&D 5319

Perioperative Quality Improvement Programme: Patient Study

Over ten million operations take place in the UK NHS every year. The number of patients which are at high risk of adverse postoperative outcomes has grown substantially in recent years: this is attributable to a combination of an ageing population, the increased numbers of surgical options available for previously untreatable conditions, and the increasing numbers of patient presenting surgery with multiple comorbidities. Estimate of inpatient mortality after non-cardiac surgery range between 1.5 and 3.6% depending on the type of surgery and patient related risks. Major or prolonged postoperative morbidity occur in up to 15% of patients, and is associated with reduced long-term survival and worse health-related quality of life; this signal has been consistently demonstrated across different types of surgery, patient and healthcare systems.

This study will gather and analyse patient data for the newly established National Perioperative Quality Improvement Programme. PQIP will measure complications and outcomes from the patient perspective after major surgery. Patients will be approached at random, in participating hospitals, to give consent to have their data collected and used for research. The data collected will include information about patients, the surgery that they undergo, and the care that they receive.

The study aim is to comprehensively measure, report and improve risk-adjusted outcome from major surgery in the United Kingdom.

Chief Investigator – Professor SR Moonesinghe

Principal Investigator – Sarah Martindale

As anaesthetists, one of our primary roles is maintaining the patient’s airway during anaesthesia. Very rarely (1/50,000 anaesthetics) an anaesthetist is unable to either insert one of these tubes or provide oxygen to the patient in any other way which may result in brain damage due to harmfully low oxygen levels (hypoxia) or death. The solution to these situations, involves accessing the airway through an incision in the front of the neck (emergency Front of Neck Airway).

All anaesthetists are taught the practical steps involved, and the procedure itself is relatively easy to perform. Delay in making this decision is often the most common problem, yet very little research has been done examining the actual decision making required to perform this life saving procedure.

The aims of this study are to:

• Understand the thought process undergone by professionals needing to perform this task
• Identify reasons for any delay in making this decision

An experienced psychologist will carry out confidential semi-structured interviews with individuals whom have performed or attempted this emergency procedure within the past 2 years. It is hoped that the reasons why anaesthetists are reluctant to make this lifesaving decision could be elucidated. In doing so, these factors could be addressed in education and training of the workforce with the ultimate intention of making airway management and therefore anaesthesia safer for all patients.

Project Details
Principal Investigator: Dr Lawrence Kidd
Planned End Date: 01/05/2022
Local Ref: 4675

PQIP will measure complications after major planned surgery and seek to improve these outcomes through feedback of data to clinicians. A REC/CAG application for the PQIP Database has already received a favourable opinion. This analysis will answer important research questions about variation in quality of care in major surgery. We expect that this substantial collaborative work will lead to valuable insights regarding the ways in which hospitals use data to drive improvements in care.

Project Details
Principal Investigator: Mrs Sarah Martindale
Planned End Date: 31/10/2023
Local Ref: 3952