Liver Transplant Clinical Trials

Clinical trials related to Liver Transplant Procedure

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 (4) 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 (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
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
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
François Martin Carrier, MD
francois.martin.carrier.med@ssss.gouv.qc.ca
514-890-8000
Backup
Manuela Mbacfou, MSc
manuela.mbacfou.temgoua.chum@ssss.gouv.qc.ca
514-890-8000
Time Frame
Start Date: 2023-04-25
Estimated Completion Date: 2026-03
Participants
Target number of participants: 138
Treatments
Experimental: Restrictive group - Low splanchnic blood volume Restrictive fluid management strategy
This strategy first consists of performing a phlebotomy without fluid replacement at the start of surgery. Fluids are restricted to prevent excessive fluid administration and its effects on splanchnic blood volume and blood loss, in addition to the effects of phlebotomy, and to limit fluid overload. Fluids are administered to compensate for blood loss and treat severe hemodynamic instability. The blood collected by phlebotomy is transfused back at the beginning of the reperfusion phase, where fluid management will be based on goal-directed therapy (GDT) using either Pulse Pressure Variation (PPV) or Stroke Volume (SV), as in the control group.
Active_comparator: Liberal group - Optimized cardiac output liberal fluid management strategy
This strategy involves administering 250 ml fluid boluses until SV stops increasing by more than 10% or until PPV is below 12%.
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