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Search / Trial NCT05647733

Restrictive Fluid Management In Liver Transplantation (REFIL)

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Dec 8, 2022

Trial Information

Current as of January 16, 2025

Recruiting

Keywords

Hemodynamic Management Fluid Management Transfusions Phlebotomy

ClinConnect Summary

The REFIL clinical trial is looking at two different ways to manage fluids during liver transplantation surgery. The goal is to see which method works better for patients with end-stage liver disease. One approach involves using less fluid during surgery, while the other uses more fluid to maintain heart function. Researchers want to find out if it's possible to recruit at least four patients each month across three hospitals for this study, and they will also monitor how well the procedures are followed and how patients do after surgery.

To be eligible for this trial, participants must be adults aged 18 or older who are having a liver transplant due to end-stage liver disease. However, individuals with certain health issues, like severe kidney failure or serious anemia, or those needing transplants for reasons other than liver disease, won't be able to join. If someone is accepted into the trial, they can expect to receive either the restrictive or liberal fluid management strategy during their surgery, and their progress will be tracked for 30 days and again at six months after the procedure. This study is currently recruiting participants.

Gender

ALL

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

Trial Officials

Francois-Martin Carrier, MD

Principal Investigator

Centre hospitalier université de Montréal

About Centre Hospitalier De L'université De Montréal (Chum)

The Centre Hospitalier de l'Université de Montréal (CHUM) is a leading academic health institution in Canada, dedicated to advancing patient care through innovative research and clinical excellence. As a prominent sponsor of clinical trials, CHUM is committed to leveraging its multidisciplinary expertise and state-of-the-art facilities to facilitate groundbreaking studies that enhance medical knowledge and improve health outcomes. Collaborating with a network of healthcare professionals and researchers, CHUM fosters a rigorous research environment that prioritizes patient safety, ethical standards, and scientific integrity, positioning itself at the forefront of medical advancements.

Locations

Montréal, Quebec, Canada

London, Ontario, Canada

Montréal, Quebec, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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