Emergency, ITU and Surgery Clinical Trials
The following studies are being carried out at the Somerset Foundation Trust.
ASTOP – Antifungal stewardship opportunities with rapid tests for fungal infection in critically ill patients
The purpose of this project is to assess the performance of three rapid tests for fungal infection. The accuracy of these tests will be compared and the optimal test (or combination) identified. The emphasis will be on their ability to rule-out infection.
Planned end of recruitment date: 17/04/2022
Genomicc – Genetics Of Mortality In Critical Care
GenOMICC is an open-source research study that aims to engage and unite clinicians and scientists from all over the world to understand the genetic factors that change outcome in critical illness. Susceptibility to COVID-19 is almost certainly, in part, genetic. GenOMICC can find the genes that cause susceptibility, which may help us to prioritise treatments to respond to the global crisis. GenOMICC was designed for this crisis. Since 2016, the open, global GenOMICC collaboration has been recruiting patients with emerging infections, including COVID-19. All patients with confirmed COVID-19 in critical care are eligible for GenOMICC; please recruit them as normal, following local infection control precautions.
Planned end of recruitment date: 31/08/2029
REMAP-CAP – Adaptive Platform trial for Community Acquired Pneumonia & COVID-19
Community-acquired pneumonia (CAP) is a syndrome in which individuals who have not been hospitalised recently develop an acute infection of the lungs. Bacterial and viral infections are responsible for the vast majority of CAP. CAP is a leading cause of death from infection globally, with lower respiratory tract infection implicated in approximately 3 million deaths in 2016. This makes it the fourth most common cause of death world-wide, and the leading cause of death in developing countries. CAP that is severe enough to require admission to an Intensive Care Unit (ICU) is associated with substantial risk of mortality. All patients who are treated in an ICU will receive therapy that consists of multiple different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don’t always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best.
Planned end of recruitment date: 30/06/2022
RECOVERY-RS – Respiratory Support: Respiratory Strategies in COVID-19; CPAP, High-flow, and standard care
A range of potential treatments have been suggested for COVID-19 but nobody knows if any of them will turn out to be more effective in helping people recover than the usual standard of hospital care which all patients will receive. The RECOVERY-RS trial will compare the effectiveness of three ventilation methods;
- Continuous positive airway pressure (CPAP): this treatment applies mild to high air pressure on a continuous basis through a tightly fitted face mask. It keeps the airways continuously open in people who are able to breathe normally on their own, but need help keeping their airway clear.
- High flow nasal oxygen (HFNO): this is a way of giving humidified (moistened) and warmed oxygen through tubes into the nose. The oxygen is delivered very quickly to help patients who have low oxygen levels and find breathing on their own difficult.
- Standard care: standard treatment will involve oxygen delivered via a normal face mask or tubes in the nose.
Planned end of recruitment date: 31/12/2021
A2B – Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): A randomised, parallel-group, allocation concealed, controlled, open, phase 3 pragmatic clinical and cost effectiveness trial with internal pilot.
Many patients in intensive care (ICU) need help to breathe on a breathing machine and need pain killers and sedatives to keep them comfortable and pain free. However, keeping patients too deeply sedated can make their ICU stay longer, can cause ICU confusion (delirium) and afterwards may cause distressing memories. Ideally we want to keep patients less sedated, but it is difficult to get the balance of sedation and comfort right. The purpose of this study is to compare if patients on dexmedetomidine or clonidine come off the ventilator quicker than those just on propofol. We will also see if there was a difference between the groups in the number of people who experienced delirium in ICU, compare how comfortable people were and measure if participants memories of being in ICU differed.
Planned end of recruitment date: 31/10/2022
STRESS-L – Study into the reversal of septic shock with Landiolol (Beta Blockade).
STRESS-L is an open-label, multicentre randomised controlled trial comparing the use of Landiolol (beta blockade) infusion with standard care versus standard care alone in septic shock patients. The trial aims to investigate if Landiolol improves mean organ failure scores during ICU admission.
Planned end of recruitment date: 01/02/2022
GAP – Gabapentin in post-surgery pain
About 4.5 million people undergo surgery each year in the UK. Most patients experience pain after surgery. Good pain control is essential to recovery. Opioids (e.g. morphine) are typically prescribed to control the pain. Opioids are effective but carry side effects such as sleepiness, sickness and low blood pressure. These side effects prevent recovery and keep patients in hospital for longer. Gabapentin is an alternative medication that doctors are increasingly prescribing for pain relief after surgery. We don’t know whether giving gabapentin alongside opioids and other drugs improves pain control, leading to fewer side effects overall and a quicker recovery. This is the question the GAP study is aiming to answer.
Planned end of recruitment date: 31/05/2022 https://bristoltrialscentre.blogs.bristol.ac.uk/details-of-studies/gap/
The PITSTOP Study: Pilonidal sinus Treatment: Studying the Options. We are investigating the most effective forms of treatment for Pilonidal Sinus disease.
Pilonidal sinus disease is a small hole or tunnel in the skin between the buttocks. It can fill with puss or fluid and this can lead to the formation of an abscess or a cyst. It usually contains hair or debris. The treatment for pilonidal sinus disease is surgery. There are various surgeries that can be done to treat pilonidal sinus disease.
This study is looking at the different severities of the disease and the different ways in which these are treated. It also aims to find out what matters the most to patients in regards to their treatments. This will help understand what treatments show the best results for the treatment of pilonidal sinus disease and also what is most important to patients when they are choosing their treatment options.
Study: Open to Recruitment
Still actively recruiting patients eligible for this study.
A randomised controlled trial to establish the clinical and cost effectiveness of expectant management versus pre-operative imaging with magnetic resonance cholangiopancreatography (MRCP) in patients with symptomatic gallstones undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones: The Sunflower Study.
https://sunflowerstudy.blogs.bristol.ac.uk/, Twitter @SunflowerStudy
Study: Open to Recruitment
The ESCP Safe-anastomosis Programme in Colorectal Surgery (EAGLE) is an international, cluster randomised-sequence study of a Safe-anastomosis Quality Improvement Intervention to reduce anastomotic leak following right colectomy and ileocaecal resection.
Planned closing date 30/12/2021
Defining the Denominator:
Emergency Laparotomy and Frailty Study 2
Identify a U.K. consecutive series of older adults presenting with acute abdominal pathology potentially treatable by emergency laparotomy where the decision is made not to undergo surgery (NoLAP) and their associated 90-day mortality.
Planned closing date 02/11/2021