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Restrictive Fluid Management In Liver Transplantation (REFIL)

RecruitingNAAges 18 Years - anyAllCentre hospitalier de l'Université de Montréal (C…
NCT07695363 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of the REFIL-2 study is to evaluate the effectiveness of a low splanchnic blood volume restrictive fluid management strategy (a strategy that involves limiting fluid administration and prioritizing the use of medications that raise blood pressure during surgery, combined with phlebotomy) in improving patients' recovery after surgery. The study compares the low splanchnic blood volume restrictive fluid management strategy to an optimized cardiac-output liberal fluid management strategy (which involves administering more fluids to raise blood pressure with less reliance on medications). Outcomes important to patients will be measured. This study (REFIL-2) had a vanguard phase (internal pilot) that included 138 patients (NCT05647733). The patients included in the vanguard pilot phase were not compared between groups but only analyzed descriptively using aggregated data. Only feasi

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult ≥ 18 years old 2. Undergoing liver transplantation (LT) 3. End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation. Exclusion Criteria: 1. Undergoing LT for an indication other than ESLD (e.g., acute liver failure, primary liver cancer without ESLD, retransplantation, amyloid neuropathy, polycystic liver disease, or any other indication not associated with ESLD) 2. Undergoing combined solid organ transplantations 3. Any of the following conditions: * severe chronic renal failure (GFR \< 15 ml/minute/1.73 m2 \[CKD-EPI equation\] or already on renal replacement therapy (RRT)) * severe anemia (hemoglobin level \< 80 g/L) * hemodynamic instability (norepinephrine equivalent \> 10 ug/min) 4. Physician refusal to enroll the patient.
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What it tests

  • Low splanchnic blood volume restrictive fluid management strategy
  • Phlebotomy
  • Optimized cardiac output liberal fluid management strategy
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Where

4 sites
Vancouver General Hospital (VGH)
Vancouver, Canada
London Health Sciences Centre (LHSC)
London, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Canada
McGill University Health Centre (MUHC)
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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