Restrictive Fluid Management for Liver Transplant
(REFIL-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of the REFIL-2 study is to evaluate the effectiveness of a low splanchnic blood volume restrictive fluid management strategy (a strategy that involves limiting fluid administration and prioritizing the use of medications that raise blood pressure during surgery, combined with phlebotomy) in improving patients' recovery after surgery. The study compares the low splanchnic blood volume restrictive fluid management strategy to an optimized cardiac-output liberal fluid management strategy (which involves administering more fluids to raise blood pressure with less reliance on medications). Outcomes important to patients will be measured.
This study (REFIL-2) had a vanguard phase (internal pilot) that included 138 patients (NCT05647733). The patients included in the vanguard pilot phase were not compared between groups but only analyzed descriptively using aggregated data. Only feasibility metrics were compared (see NCT05647733). These 138 patients were thus rolled into the REFIL-2 trial and included in the final sample size reported herein.
Who Is on the Research Team?
François Martin Carrier, MD
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Are You a Good Fit for This Trial?
This trial is for people with severe liver disease or failure who are undergoing a liver transplant. Participants must be eligible for surgery and able to follow the study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo liver transplantation with either a restrictive or liberal fluid management strategy during surgery
Postoperative Monitoring
Participants are monitored for severe complications and other outcomes up to hospital discharge or 30 days post-surgery
Follow-up
Participants are monitored for clinical outcomes, quality of life, and survival for 12 months post-transplantation
What Are the Treatments Tested in This Trial?
Interventions
- Low splanchnic blood volume restrictive fluid management strategy
- Optimized cardiac output liberal fluid management strategy
- Phlebotomy
Trial Overview
The study compares two ways of managing fluids during liver transplant: one group gets less fluid plus medications and blood removal (restrictive strategy), while the other receives more fluids to keep blood pressure up (liberal strategy). Patients are randomly assigned to each approach.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
A phlebotomy (a procedure where the patient's blood is drawn, similar to a blood donation, without fluid replacement) at the start of the surgery combined with fluid restriction (use of vasopressor preferentially to treat hemodynamic instability with tolerance to relative hypovolemia defined as a Pulse Pressure Variation (PPV) or Stroke Volume (SVV) up to 18%). Fluids will be administered to compensate for blood loss and/or treat severe hemodynamic instability. Blood collected by phlebotomy will always be transfused back at the beginning of the reperfusion phase, during which fluid management will be based on goal-directed therapy (GDT) using either PPV or SV, as in the control group.
Goal-directed therapy (GDT): Patients will receive 250 ml fluid boluses until SV stops increasing by more than 10% or until PPV is below 12%. Fluids will thus be used preferentially to treat hemodynamic instability. Fluids will also be administered to compensate for blood loss and/or treat severe hemodynamic instability.
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
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