Actively Recruiting
Restrictive Fluid Management In Liver Transplantation (REFIL)
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-02-23
138
Participants Needed
4
Research Sites
148 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Restrictive Fluid Management In Liver Transplantation (REFIL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older undergoing liver transplantation for end-stage liver disease
You will not qualify if you...
- Patients undergoing liver transplant for reasons other than end-stage liver disease such as acute liver failure, liver cancer without ESLD, retransplantation, amyloid neuropathy, or other non-ESLD indications
- Patients receiving combined liver and lung or liver and heart transplantation
- Patients with severe chronic renal failure (GFR less than 15 ml/min/1.73 m2 or on renal replacement therapy)
- Patients with severe anemia (hemoglobin level less than 80 g/L)
- Patients with hemodynamic instability requiring norepinephrine equivalent greater than 10 ug/min
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
2
London Health Sciences Centre
London, Ontario, Canada, N6G 2V4
Actively Recruiting
3
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
4
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
F
François Martin Carrier, MD
CONTACT
M
Manuela Mbacfou, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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