Restrictive Fluid Management In Liver Transplantation (REFIL)

Condition(s) studied

Investigational drug(s) / intervention(s)

Low splanchnic blood volume restrictive fluid management strategy: Hemodynamic goal-directed restrictive fluid management strategy

Phlebotomy: Blood drawn in a blood donation bag prior to dissection and transfused back after graft reperfusion

Optimized cardiac output liberal fluid management strategy: Permissive hemodynamic goal-directed fluid management strategy that optimizes cardiac output throughout surgery

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of participants with at least one severe complication — Up to hospital discharge (from surgery to hospital discharge) or 30 days, whichever comes first
  Incidence of at least one severe complications defined as a complication of grade ≥ 3 according to the Dindo-Clavien scale (grade 1 to 5)

Trial sites (4)

More Centre hospitalier de l'Université de Montréal (CHUM) trials in Canada

Other trials for the same condition