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Restrictive Fluid Management In Liver Transplantation (REFIL)

ConditionsLiver Transplantation (LT)End-stage Liver Disease (ESLD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult ≥ 18 years old

Undergoing liver transplantation (LT)

End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation.

Disqualifiers

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

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low splanchnic blood volume restrictive fluid management strategy

    Procedure/Surgery

    Hemodynamic goal-directed restrictive fluid management strategy

  • Phlebotomy

    Procedure/Surgery

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

  • Optimized cardiac output liberal fluid management strategy

    Procedure/Surgery

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

Treatment groups

866 Participants
are divided into 2 treatment groups
Group A: Restrictive group - Low splanchnic blood volume restrictive fluid management strategyExperimental treatment 2 interventions
Group B: Liberal group - Optimized cardiac output liberal fluid management strategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with at least one severe complication

Incidence of at least one severe complications defined as a complication of grade ≥ 3 according to the Dindo-Clavien scale (grade 1 to 5)

Time frame
Up to hospital discharge (from surgery to hospital discharge) or 30 days, whichever comes first

Secondary outcomes

1

Number of participants who were transfused at least one unit of red blood cells (RBC) during the perioperative period of surgery

Incidence of participants transfused at least 1 unit of RBC during the perioperative period of surgery

Time frame
During surgery (from entrance in the operating to exit of the operating room) and up to 48 hours after surgery (from exit of the operating room to 48 hours after exit of the operating room)
2

Number of participants who were transfused at least one unit of red blood cells (RBC) during surgery

Incidence of at least one RBC transfusion during surgery

Time frame
Intraoperative (from entrance in the operating room to exit of the operating room)
3

Intraoperative blood loss

Blood loss as estimated by clinicians

Time frame
Intraoperative (from entrance in the operating room to exit of the operating room)
4

7-day quality of recovery

Quality of recovery measured using the 15-item Quality of Recovery (QoR-15) score. Each item is scored on an 11-point numerical rating scale (0-10) for a total between 0 and 150, 0 being the worst possible recovery and 150 being a perfect recovery.

Time frame
One time point: 7 days after surgery (transplantation)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Canadian Donation and Transplantation Research Program (CDTRP)

Collaborator

Canadian Perioperative Anesthesia Clinical Trial (PACT) Group

Collaborator

Source ClinicalTrials.gov
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