Restrictive Fluid Management In Liver Transplantation (REFIL) - Pilot

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Phlebotomy: Retrieval of blood in a blood donation bag performed prior to dissection and transfused back after graft reperfusion

Study summary

Hypothesis: A Canadian multicentre clinical trial is feasible. Study Design: Multicenter internal pilot parallel arm randomized controlled trial.

Study population: Patients with end-stage liver disease (ESLD) undergoing a liver transplantation, not meeting any exclusion criteria.

Primary feasibility endpoint: An overall recruitment rate ≥ 4 patients/month across all four participating sites.

Secondary feasibility endpoints: A protocol adherence \> 90%, a 30-day (or hospital discharge) and 6-month outcome measurement \> 90%, and a mean difference in total intraoperative volume received (crystalloids and colloids combined) \> 1000 ml between groups.

Study intervention: Low splanchnic blood volume restrictive fluid management strategy (intervention). A phlebotomy, performed prior to dissection and transfused back after graft reperfusion, combined with a hemodynamic goal-directed restrictive fluid management strategy.

Optimized cardiac-output liberal fluid management strategy (control) A hemodynamic goal-directed liberal fluid management strategy that optimizes cardiac output throughout surgery.

Eligibility

Primary outcome measure(s)

• Recruitment rate — 36 months (at study level)
  Overall recruitment rate ≥ 4 patients/month (across all sites)
• Adherence — At time of surgery
  Protocol adherence \> 90%, determined using a questionnaire
• Hospital outcome measurement completeness — At 30 days (or hospital discharge) after surgery
  A 30 days or hospital discharge outcome measurement \> 90%
• 6-month outcome measurement completeness — 6 months after surgery
  6-month outcome measurement \> 90%
• Mean difference in total volume received — At time of surgery
  A mean difference in total volume received (crystalloids and colloids combined) \> 1000 ml between groups.

Trial sites (4)

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