Restrictive Fluid Management In Liver Transplantation (REFIL)

Phase

N/A

Condition

Liver Transplantation

Treatment

Low splanchnic blood volume restrictive fluid management strategy

Optimized cardiac output liberal fluid management strategy

Phlebotomy

Clinical Study ID

NCT05647733

2023-11173

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

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 undergoing a liver transplantation not meeting any exclusion criteria.

Primary endpoint: The primary feasibility endpoint is an overall recruitment rate ≥ 4 patients/month across all three participating sites.

Secondary endpoint: The secondary feasibility endpoints are 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Any adult patient ≥ 18 years of age undergoing liver transplantation for ESLD.

Exclusion

Exclusion Criteria:

Patients undergoing LT for an indication other than ESLD such as acute liverfailure, liver cancer without ESLD, retransplantation, amyloid neuropathy or anyother indication not associated with ESLD.
Patients undergoing a combined liver and lung or liver and heart transplantation.
Patients with any of the following conditions:
severe chronic renal failure (GFR < 15 ml/minute/1.73 m2 [CKD-EPI equation] oralready on RRT);
severe anemia (hemoglobin level < 80 g/L);76,93,109
hemodynamic instability (norepinephrine equivalent > 10 ug/min).

Study Design

Low splanchnic blood volume restrictive fluid management strategy

April 25, 2023

January 01, 2026

Study Description

MAIN OBJECTIVE The main objective of the REFIL-1 pilot study is to establish the feasibility (recruitment, adherence, outcome measurement) of conducting a Canadian multicentre randomized controlled trial comparing an intraoperative low-splanchnic blood volume restrictive fluid management strategy to a cardiac output optimised liberal fluid management strategy in adult LT for ESLD. The hypothesis is that a Canadian multicentre clinical trial is feasible.

SECONDARY OBJECTIVES The overarching objective of the ReFIL (Restrictive Fluid management In Liver transplantation) research program, which will be answered in a future large-scale trial, regards the efficacy of the proposed interventional strategy to improve postoperative outcomes in LT.

TERTIARY OBJECTIVES Our tertiary objective is to measure the cost-effectiveness of the proposed intervention based on the composite outcome of any severe postoperative complications and graft loss.

DESIGN AND STUDY POPULATION This study a multicentre internal pilot parallel arm randomized trial comparing two intraoperative hemodynamic and splanchnic blood volume management strategies in LT recipients.

Connect with a study center

London Health Sciences Centre
London, Ontario N6G 2V4
Canada
Active - Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec H2X 0C1
Canada
Active - Recruiting
McGill University Health Centre
Montréal, Quebec H4A 3J1
Canada
Active - Recruiting

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