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Not Yet Recruiting NCT05647733

Restrictive Fluid Management In Liver Transplantation (REFIL)

Conditions: Liver Transplantation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 72
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Location: Canada

Summary

Hypothesis: A Canadian multicentre clinical trial is feasible. Study Design: Multicenter internal pilot parallel arm randomized controlled trialStudy 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 strategyOptimized cardiac-output liberal fluid management strategy (control) A hemodynamic goal-directed liberal fluid management strategy that optimizes cardiac output throughout surgery

Eligibility 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);76,93,109hemodynamic instability (norepinephrine equivalent > 10 ug/min).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05647733). StuddyBuddy aggregates publicly available trial information.