Restrictive fluid management during liver transplantation
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
This study is testing two different ways of managing fluids during liver transplants to see which one helps patients with end-stage liver disease recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 4 sites (Vancouver, British Columbia and 3 other locations) |
| Trial ID | NCT05647733 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the feasibility of a multicenter randomized controlled trial comparing two fluid management strategies during liver transplantation for patients with end-stage liver disease. The study will evaluate a low splanchnic blood volume restrictive fluid management approach against a cardiac output optimized liberal fluid management strategy. Key endpoints include recruitment rates, protocol adherence, and differences in intraoperative fluid volumes. The ultimate goal is to establish a foundation for a larger trial that could improve postoperative outcomes and cost-effectiveness in liver transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing liver transplantation for end-stage liver disease.
Not a fit: Patients with conditions such as acute liver failure, liver cancer without ESLD, or severe hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes for patients undergoing liver transplantation.
How similar studies have performed: Other studies have explored fluid management strategies in liver transplantation, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Vancouver, British Columbia and 3 other locations
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Francois Martin Carrier, MD — Centre hospitalier université de Montréal
- Study coordinator: François Martin Carrier, MD
- Email: francois.martin.carrier.med@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.