NCT07695363Recruiting
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)
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 866 (estimated)
- First submitted
- 15 Jun 2026
- Start date
- 15 Feb 2026
- Primary completion date
- Nov 2030
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- NCT number
- NCT07695363
What you commit to
- Study type: Interventional
- Planned participants: 866
- From 15 Feb 2026 to the primary completion date, Nov 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- 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)
Other
- Undergoing combined solid organ transplantations
- Physician refusal to enroll the patient.
Who the study is looking for
- Adult ≥ 18 years old
- Undergoing liver transplantation (LT)
- End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre (LHSC) Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| McGill University Health Centre (MUHC) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Vancouver General Hospital (VGH) Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.