Intraoperative Hemodynamic Management and Postoperative Outcomes in Liver Transplantation

NCT04732689 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 852

Last updated 2025-02-05

No results posted yet for this study

Summary

The overarching objective of the research program entitled ELIPTO (Enhancing Liver Insufficiency and Postoperative Transplantation Outcomes) (www.elipto.ca) is to improve the perioperative care of liver transplant recipients. One of this program's purposes is to better define the effects of intraoperative hemodynamic management on postoperative outcomes in adult liver transplant recipients. In this study, the incidence of postoperative complications within this population will be defined in Canada and France and the association between intraoperative hemodynamics and postoperative outcomes will be measured.

Liver transplantation improves the survival of patients with end-stage liver disease (ESLD). It is the second most transplanted organ with a continuously increasing annual number of transplantations, an observation partly explained by an endemic ESLD etiology in the United States, the obesity-related non-alcoholic steatohepatitis (NASH) cirrhosis. In recent decades, although sicker patients are prioritized, survival has improved possibly through an overall improvement in the quality of care. However, postoperative complications have concomitantly increased. On average, liver transplant recipients suffer from more than three postoperative complications, mainly infectious, pulmonary, renal or graft-related, two thirds of them being severe. In a low-risk patients cohort, close to 60% of all patients suffered from at least one severe complication up to 6 months after surgery. Such complications increase mortality, readmissions and cost of care. Organs available for transplantation are a scarce resource; up to 10% of grafts are no longer functional after one year. Interventions that improve patients' postoperative and graft outcomes are needed and few perioperative ones are supported by high-quality evidence.

Conditions

  • Liver Failure
  • Liver Diseases
  • Surgery
  • Surgery--Complications
  • Transplant; Failure, Liver

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER
  • Toronto General Hospital

    collaborator OTHER
  • London Health Sciences Centre

    collaborator OTHER
  • University of Alberta

    collaborator OTHER
  • Queen Elizabeth II Health Sciences Centre

    collaborator OTHER
  • Hopital Paul Brousse

    collaborator OTHER
  • Pitié-Salpêtrière Hospital

    collaborator OTHER
  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • François-Martin Carrier, MD, FRCPC · Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-06-30
Completion
2023-11-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732689 on ClinicalTrials.gov