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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Design: Multicenter internal pilot parallel arm randomized controlled trial Study population: Patients with end-stage liver disease undergoing a liver transplantation not meeting any exclusion criteria. Primary endpoint: The primary feasibility endpoint is an overall recruitment rate ≥ 4 patients/month across all three participating sites. Secondary endpoint: The secondary feasibility endpoints are 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Any adult patient ≥ 18 years of age undergoing liver transplantation for ESLD.

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Centre Hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
Contact Information
Primary
François-Martin Carrier, MD
francois.martin.carrier.med@ssss.gouv.qc.ca
514-890-8000
Backup
Martine Lebrasseur, RN
martine.lebrasseur.chum@ssss.gouv.qc.ca
514-890-8000
Time Frame
Start Date: 2023-04-25
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 72
Treatments
Experimental: Restrictive group: Low splanchnic blood volume Restrictive fluid management strategy
The intervention group is targeted at lowering splanchnic blood volume using a phlebotomy and restricting fluid infusion, individualized to the physiological needs of this population and the distinct LT surgical phases. The strategy will first consist of performing a phlebotomy without fluid replacement at the start of surgery.We will combine it with fluid restriction to prevent excessive fluid administration and its effect on splanchnic blood volume and blood loss, combined with the effect of the phlebotomy, as well as to limit fluid overload, as previously reported. Fluid will be administered to compensate blood loss and treat severe hemodynamic instability.The phlebotomy will be transfused back at the beginning of the reperfusion phase where fluid management will be based on a goal-directed therapy (GDT) using either PPV or SV, as in the control group.
Active_comparator: Liberal group: Optimized cardiac output liberal fluid management strategy
The control group will receive a liberal intraoperative fluid management strategy optimizing cardiac output throughout the surgery. It will consist of administering 250 mL fluid boluses until SV stops to increase by more than 10% or until PPV is below 12%, a dynamic indicator of fluid responsiveness validated in many surgical populations, including ESLD patients undergoing a LT.This strategy is informed by data from recent clinical trials on benefits of GDT in major surgery, data on strategies used in major surgery, liver resection or LT and our survey on current practice.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Canadian Donation and Transplantation Research Program (CDTRP), Canadian Perioperative Anesthesia Clinical Trial (PACT) Group
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov