RecruitingNot ApplicableNCT07695363

Restrictive Fluid Management In Liver Transplantation (REFIL)

Effects of an Intraoperative Low-splanchnic Blood Volume Restrictive Fluid Management Strategy Compared to a Cardiac Output Optimized Liberal Fluid Management Strategy on Postoperative Outcomes in Liver Transplantation: A Multicenter Randomized Controlled Trial (REFIL-2)


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

866 participants

Start Date

Feb 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Low splanchnic blood volume restrictive fluid management strategy, a procedure called Optimized cardiac output liberal fluid management strategy, and others for people with end-stage liver disease (esld) and liver transplantation (lt). The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELow splanchnic blood volume restrictive fluid management strategy

Hemodynamic goal-directed restrictive fluid management strategy

PROCEDUREPhlebotomy

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

PROCEDUREOptimized cardiac output liberal fluid management strategy

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


Locations(4)

Vancouver General Hospital (VGH)

Vancouver, British Columbia, Canada

London Health Sciences Centre (LHSC)

London, Ontario, Canada

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

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NCT07695363


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