NCT07695363 Restrictive Fluid Management In Liver Transplantation (REFIL)
| NCT ID | NCT07695363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Liver Transplantation (LT) |
| Study Type | INTERVENTIONAL |
| Enrollment | 866 participants |
| Start Date | 2026-02-15 |
| Primary Completion | 2030-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 866 participants in total. It began in 2026-02-15 with a primary completion date of 2030-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Adult ≥ 18 years old 2. Undergoing liver transplantation (LT) 3. End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation. Exclusion Criteria: 1. 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) 2. Undergoing combined solid organ transplantations 3. Any of the following conditions: * 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) * hemodynamic instability (norepinephrine equivalent \> 10 ug/min) 4. Physician refusal to enroll the patient.
Contact & Investigator
François Martin Carrier, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT07695363 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplantation (LT). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07695363 currently recruiting?
Yes, NCT07695363 is actively recruiting participants. Contact the research team at manuela.mbacfou.temgoua.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT07695363 trial being conducted?
This trial is being conducted at Vancouver, Canada, London, Canada, Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT07695363 clinical trial?
NCT07695363 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is François Martin Carrier, MD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 866 participants.