Restrictive Fluid Management for Liver Transplant Patients
(REFIL Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a method of carefully managing fluids during liver transplant surgery for patients with severe liver disease. The goal is to see if this approach can reduce complications and improve recovery by keeping blood volume in the abdominal organs low. This method has been shown to reduce complications following various major surgeries.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the restrictive fluid management treatment for liver transplant patients?
Research suggests that using a restrictive fluid management strategy during liver transplants can reduce complications like acute kidney injury (AKI) and surgical bleeding compared to more liberal fluid approaches. This is because it helps maintain better blood flow balance and reduces the risk of fluid overload, which can harm kidney function and increase bleeding risk.12345
Is restrictive fluid management safe for liver transplant patients?
How is the restrictive fluid management strategy unique for liver transplant patients?
The restrictive fluid management strategy for liver transplant patients is unique because it focuses on maintaining low splanchnic blood volume to reduce complications like bleeding and acute kidney injury, unlike traditional approaches that use liberal fluid administration which can worsen surgical bleeding and affect kidney function.23478
Research Team
Francois-Martin Carrier, MD
Principal Investigator
Centre hospitalier université de Montréal
Eligibility Criteria
The REFIL trial is for adults over 18 years old who need a liver transplant due to end-stage liver disease (ESLD). It's not for those with acute liver failure, cancer without ESLD, retransplantation, amyloid neuropathy, severe kidney failure (GFR < 15), severe anemia (hemoglobin < 80 g/L), or hemodynamic instability.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intraoperative Treatment
Participants undergo liver transplantation with either a restrictive or liberal fluid management strategy
Postoperative Follow-up
Participants are monitored for postoperative outcomes, including complications and graft function
Extended Follow-up
Participants are monitored for long-term outcomes, including survival and quality of life
Treatment Details
Interventions
- Low splanchnic blood volume Restrictive fluid management strategy (Procedure)
- Optimized cardiac output liberal fluid management strategy (Procedure)
Low splanchnic blood volume Restrictive fluid management strategy is already approved in Canada for the following indications:
- Liver Transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Canadian Donation and Transplantation Research Program (CDTRP)
Collaborator
Canadian Perioperative Anesthesia Clinical Trial (PACT) Group
Collaborator