Restrictive Fluid Management In Liver Transplantation (REFIL)
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
Centre hospitalier de l'Université de Montréal (CHUM)
138 participants
Apr 25, 2023
INTERVENTIONAL
Conditions
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 (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.
Eligibility
Inclusion Criteria1
- Any adult patient ≥ 18 years of age undergoing liver transplantation for ESLD.
Exclusion Criteria6
- 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).
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Interventions
Hemodynamic goal-directed restrictive fluid management strategy
Permissive hemodynamic goal-directed fluid management strategy that optimizes cardiac output throughout surgery
Retrieval of blood in a blood donation bag performed prior to dissection and transfused back after graft reperfusion
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05647733