NCT05647733Active, not recruiting
Restrictive Fluid Management In Liver Transplantation (REFIL) - Pilot
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 Pilot Multicenter Randomized Controlled Trial (REFIL-1)
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 30 Nov 2022
- Start date
- 25 Apr 2023
- Primary completion date
- 24 Feb 2026
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- NCT number
- NCT05647733
What you commit to
- Study type: Interventional
- Planned participants: 138
- From 25 Apr 2023 to the primary completion date, 24 Feb 2026
- 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
- Patients undergoing LT for an indication other than ESLD such as acute liver failure, liver cancer without ESLD, retransplantation, amyloid neuropathy or any other indication not associated with ESLD.
- Patients undergoing a combined liver and lung or liver and heart transplantation.
- Patients with any of the following conditions:
Lab values
- severe chronic renal failure (GFR \< 15 ml/minute/1.73 m2 \[CKD-EPI equation\] or already on RRT);
- severe anemia (hemoglobin level \< 80 g/L);76,93,109
Other
- hemodynamic instability (norepinephrine equivalent \> 10 ug/min).
Who the study is looking for
- Any adult patient ≥ 18 years of age undergoing liver transplantation for ESLD.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.