Restrictive Fluid Management In Liver Transplantation (REFIL)
Recruiting · NCT07695363 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 feasibility metrics were compared (see NCT05647733). These 138 patients were thus rolled into the REFIL-2 trial and included in the final sample size reported herein.
Who can take part
Inclusion criteria
- Adult ≥ 18 years old
- Undergoing liver transplantation (LT)
- End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation.
Exclusion criteria
- 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)
- Undergoing combined solid organ transplantations
- 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)
- Physician refusal to enroll the patient.
Where it is running
4 locations listed.
- Vancouver General Hospital (VGH) - Vancouver, British Columbia, Canada
- London Health Sciences Centre (LHSC) - London, Ontario, Canada
- Centre hospitalier de l'Université de Montréal (CHUM) - Montreal, Quebec, Canada
- McGill University Health Centre (MUHC) - Montreal, Quebec, Canada