Restrictive Fluid Management In Liver Transplantation (REFIL)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About 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.

Eligibility criteria

Qualifiers

Adult ≥ 18 years old

Undergoing liver transplantation (LT)

End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation.

Disqualifiers

Undergoing LT for an indication other than ESLD (e.g., acute liver failure, primary liver cancer without ESLD, retransplantation, amyloid neuropathy, polycystic liver disease, or any other indication not associated with ESLD)

Undergoing combined solid organ transplantations

severe chronic renal failure (GFR < 15 ml/minute/1.73 m2 [CKD-EPI equation] or already on renal replacement therapy (RRT))

severe anemia (hemoglobin level < 80 g/L)

Trial design

Treatments tested in this trial

  • Low splanchnic blood volume restrictive fluid management strategy
  • Phlebotomy
  • Optimized cardiac output liberal fluid management strategy

Treatment groups

866 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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