Skip to content

Restrictive Fluid Management In Liver Transplantation (REFIL)

Liver Transplantation

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

null

Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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:
* 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
* hemodynamic instability (norepinephrine equivalent \> 10 ug/min).

Study Location

McGill University Health Centre
McGill University Health Centre
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Stanislas Kandelman, MD

[email protected]
(514)934-1934
Centre Hospitalier de l'Université de Montréal (CHUM)
Centre Hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

François-Martin Carrier, MD

[email protected]
514-890-8000
London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contact Study Team

Primary Contact

Nelson Javier Gonzalez Valencia, MD

[email protected]
(519) 661-2111
Study Sponsored By
Centre hospitalier de l'Université de Montréal (CHUM)
Participants Required
More Information
Study ID: NCT05647733