Restrictive Fluid Management In Liver Transplantation (REFIL)

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.

NCT Number	NCT07695363
Lead Sponsor	Centre hospitalier de l'Université de Montréal (CHUM) Collaborators: Canadian Institutes of Health Research (CIHR), Canadian Donation and Transplantation Research Program (CDTRP), Canadian Perioperative Anesthesia Clinical Trial (PACT) Group
Conditions	Liver Transplantation (LT), End-stage Liver Disease (ESLD)
Enrollment	866 participants
Start Date	2026-02-15
Primary Completion	2030-11 (estimated)
Study Completion	2031-11 (estimated)
Updated on ClinicalTrials.gov	2026-07-10