Intraoperative Hemodynamic Management and Postoperative Outcomes in Liver Transplantation

NCT04732689 | Completed

• 1 other identifier: 20.353
• Study Type: observational
• Target: 852
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Occurence of primary graft dysfunction

  This outcome was chosen because preliminary data from the CHUM suggested that a higher fluid balance was associated with primary graft non-function (retransplantation or death). Since graft perfusion is correlated with cardiac output, intraoperative hemodynamic management may have an effect on graft perfusion and postoperative graft function. Also, this is a well-defined, quantitative definition, that is associated with overall graft and patient survival. Since graft loss of 10% at 1 year is a concern among the transplant community, finding causes and solutions to improve graft function is paramount.

  At 7 days after transplantation

Secondary Outcomes (13)

• Occurrence of biliary complications

  Up to 6 months after transplantation

• Occurence of biliary anastomotic strictures

  Up to 6 months after transplantation

• Liver transplant-related reoperations

  Up to 30 days after transplantation

• Retransplantation

  Up to 6 months after transplantation

• Occurence of acute kidney injury

  48 hours, 7 days and 30 days after transplantation

Study Arms (1)

Groups/Cohorts

The investigators propose to conduct a prospective observational cohort which will include all consecutive adult liver transplant recipients in each center during a one-year period but will exclude same patients who undergo a retransplantation during the same period of observation.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will include all recipients of a liver transplant across six Canadian centres, as well as in one French Centre.

You may qualify if:

• All consecutive adult liver transplant recipients in each center during a one-year period or more (anywhere in between June 1, 2021 and November 30, 2022).

You may not qualify if:

• Same patients who undergo a retransplantation during the same period of observation.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Toronto General Hospital: collaborator
• London Health Sciences Centre: collaborator
• University of Alberta: collaborator
• Queen Elizabeth II Health Sciences Centre: collaborator
• Hopital Paul Brousse: collaborator
• Pitié-Salpêtrière Hospital: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Liver Failure; Liver Diseases

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Digestive System Diseases

Study Officials

• François-Martin Carrier, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 1, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

CA (1)