Restrictive Fluid Management In Liver Transplantation (REFIL)

Summary

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.

Conditions

• Liver Transplantation (LT)
• End-stage Liver Disease (ESLD)

Interventions

PROCEDURE

Low splanchnic blood volume restrictive fluid management strategy

Hemodynamic goal-directed restrictive fluid management strategy

PROCEDURE

Phlebotomy

Blood drawn in a blood donation bag prior to dissection and transfused back after graft reperfusion

PROCEDURE

Optimized cardiac output liberal fluid management strategy

Permissive hemodynamic goal-directed fluid management strategy that optimizes cardiac output throughout surgery

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Canadian Donation and Transplantation Research Program (CDTRP)

  collaborator UNKNOWN

• Canadian Perioperative Anesthesia Clinical Trial (PACT) Group

  collaborator UNKNOWN

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• François Martin Carrier, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-15

Primary Completion

2030-11-30

Completion

2031-11-30

Countries

• Canada

Study Locations