BigpAK-2
Research type
Research Study
Full title
BIOMARKER- GUIDED INTERVENTION TO PREVENT ACUTE KIDNEY INJURY AFTER MAJOR NON-CARDIAC SURGERY - THE PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED INTERVENTIONAL TRIAL
IRAS ID
299561
Contact name
Marlies Ostermann
Contact email
Sponsor organisation
Guy's & St Thomas' NHS Foundation Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 17 days
Research summary
After major surgery, patients have a high risk of acute kidney failure, also known as acute kidney injury (AKI). At present, there is no cure for AKI, and management is limited to optimising the blood pressure and heart function, correcting dehydration and avoiding medications that could harm the kidneys.
The aim of this study is to study whether the use of an AKI bundle, ie a small straightforward set of evidence-based practices, reduces the risk of AKI after major surgery and is as safe as usual care.
For this purpose, we will randomise high risk patients to standard care versus treatment based on the bundle. Randomising means that patients will have an equal (50/50) chance of being assigned to either treatment group. We will use a new urine test to identify high risk patients.
Patients who agree to participate will have a urine test within 4 hours after major surgery. If the urine test is normal, no further actions will be taken. If the urine test shows that they are at high risk of AKI, they will be randomised to either treatment according to the practices listed in the AKI bundle for a duration of 12 hours or usual care. Treatment in the intervention group includes the optimisation of blood pressure and heart function, fluid treatment to correct dehydration and avoidance of harmful drugs.
All other treatments will be decided by the clinical teams according to departmental practice.We will record whether there are important differences between both groups up to 90 days after surgery, including development of AKI, length of stay in hospital, need for dialysis or side effects. In addition, we will measure other new kidney biomarkers in blood and urine and investigate whether they can predict the development of acute kidney failure
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0205
Date of REC Opinion
20 Sep 2021
REC opinion
Unfavourable Opinion