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Restrictive Fluid Management In Liver Transplantation (REFIL)

NCT05647733 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-02-23

No results posted yet for this study

Summary

Hypothesis: A Canadian multicentre clinical trial is feasible. Study Design: Multicenter internal pilot parallel arm randomized controlled trial.

Study population: Patients with end-stage liver disease (ESLD) undergoing a liver transplantation, not meeting any exclusion criteria.

Primary feasibility endpoint: An overall recruitment rate ≥ 4 patients/month across all four participating sites.

Secondary feasibility endpoints: A protocol adherence \> 90%, a 30-day (or hospital discharge) and 6-month outcome measurement \> 90%, and a mean difference in total intraoperative volume received (crystalloids and colloids combined) \> 1000 ml between groups.

Study intervention: Low splanchnic blood volume restrictive fluid management strategy (intervention). A phlebotomy, performed prior to dissection and transfused back after graft reperfusion, combined with a hemodynamic goal-directed restrictive fluid management strategy.

Optimized cardiac-output liberal fluid management strategy (control) A hemodynamic goal-directed liberal fluid management strategy that optimizes cardiac output throughout surgery.

Conditions

  • Liver Transplantation

Interventions

PROCEDURE

Low splanchnic blood volume restrictive fluid management strategy

Hemodynamic goal-directed restrictive fluid management strategy

PROCEDURE

Optimized cardiac output liberal fluid management strategy

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

PROCEDURE

Phlebotomy

Retrieval of blood in a blood donation bag performed prior to dissection and transfused back after graft reperfusion

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

  • Francois Martin Carrier, MD · Centre hospitalier université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647733 on ClinicalTrials.gov