REVERSE-AKI
Research type
Research Study
Full title
Restricted fluid therapy versus standard treatment in acute kidney injury - REVERSE-AKI randomised controlled pilot trial
IRAS ID
236530
Contact name
Marlies Ostermann
Contact email
Sponsor organisation
Guy's & St Thomas NHS Foundation Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Acute kidney injury (AKI), formerly known as acute renal failure, is a common complication during critical illness affecting almost 60% of patients in the Intensive Care Unit. Patients who develop AKI have an increased risk of dying, a higher risk of complications and a longer stay in hospital. There is no cure for AKI. Treatment with fluids is often necessary especially if patients are dehydrated. \n\nDuring critical illness, fluid administration is often necessary but there is increasing evidence that overzealous fluid administration and development of fluid overload are harmful and associated with an increased risk of complications, including mortality. Until recently, it was assumed that kidneys were an exception and tolerated fluid accumulation. However, there is increasing observational data showing that fluid overload in patients with AKI is associated with a higher risk of progressive deterioration of renal function and mortality.\n\nTo date, all data stem from observational studies and they don’t prove causality. The aim of this non-blinded randomised controlled trial is to investigate whether a fluid restrictive strategy in patients with AKI who are euvolaemic is associated with a significantly lower cumulative fluid balance at 72 hours and whether this approach is safe. For this reason, patients with AKI stage 1 who are euvolaemic will be randomised to a fluid strategy that focusses on prevention of fluid overload versus standard care as directed by the clinical team. To prevent fluid overload, we will only use medications and treatments that are routinely used in clinical practice, including diuretics and ultrafiltration with renal replacement therapy. The primary outcome is cumulative fluid balance at 72 hours. Secondary outcomes will be safety and feasibility outcomes.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
18/LO/0965
Date of REC Opinion
5 Sep 2018
REC opinion
Further Information Favourable Opinion