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Intraoperative Hemodynamic Management and Postoperative Outcomes in Liver Transplantation (ELIPTO-2)

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ClinicalTrials.gov Identifier: NCT04732689
Recruitment Status : Not yet recruiting
First Posted : February 1, 2021
Last Update Posted : May 17, 2021
Sponsor:
Collaborators:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Toronto General Hospital
London Health Sciences Centre
University of Alberta
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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 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.


Condition or disease
Liver Failure Liver Diseases Surgery Surgery--Complications Transplant; Failure, Liver

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Study Type : Observational
Estimated Enrollment : 470 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Hemodynamic Management and Postoperative Outcomes in Liver Transplantation: a Multicenter Prospective Cohort Study
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Occurence of primary graft dysfunction [ Time Frame: At 7 days after transplantation ]
    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.


Secondary Outcome Measures :
  1. Occurrence of biliary complications [ Time Frame: Up to 6 months after transplantation ]
    Biliary complications have major impacts on patients' quality of life, graft survival and mortality. While biliary ducts are sensible to ischemic injury, the incidence of non-anastomotic strictures have been overlooked in previous perioperative studies. Biliary complications will be classified as any stricture (anastomotic or non-anastomotic) based on medical imaging results and/or surgical, endoscopic and radiological procedures.

  2. Occurence of biliary anastomotic strictures [ Time Frame: Up to 6 months after transplantation ]
    Biliary complications will be classified as any stricture (anastomotic or non-anastomotic) based on medical imaging results and/or surgical, endoscopic and radiological procedures.

  3. Liver transplant-related reoperations [ Time Frame: Up to 30 days after transplantation ]
    Patient having to undergo any liver transplant-related reoperations up to 30 days after transplantation.

  4. Retransplantation [ Time Frame: Up to 6 months after transplantation ]
    Retransplantation is defined as the patient having to undergo a new transplantation following the index transplantation.

  5. Occurence of acute kidney injury [ Time Frame: 48 hours, 7 days and 30 days after transplantation ]
    The grade of AKI was classified according to the KDIGO-AKI criteria using the highest reported creatinine or the need for new renal replacement therapy after surgery, including any mode of renal replacement therapy.

  6. Occurence of infectious complications [ Time Frame: Up to 30 days after transplantation ]
    Infectious complications by any antibiotic prescription lasting more than 72 hours

  7. Occurrence of pulmonary complications [ Time Frame: Up to 30 days after transplantation ]
    Pulmonary complications will be classified using standardized definitions for atelectasis and ARDS.

  8. The need for a new postoperative ICU admission [ Time Frame: Up to 30 days after transplantation ]
    The dates for all ICU admissions and dates of ICU discharge were recorded. If the patient was readmitted to ICU following his initial admission to ICU, the dates for admissions and discharges were recorded.

  9. 30-day mechanical ventilation free-days [ Time Frame: Up to 30 days after transplantation ]
    The total number of days the patient was on invasive mechanical support was recorded. If mechanical ventilation was weaned and started again, the days when the patients were under mechanical ventilation were indicated. Non-invasive ventilation or high-flow nasal cannula (HFNC) were not included.

  10. 30-day organ dysfunction free days [ Time Frame: Up to 30 days after transplantation ]
    The total number of days the patient was: on invasive mechanical ventilator, under vasopressor therapy for more than 2 hours up to 30 days after surgery and spent under renal replacement therapy was recorded.

  11. Hospital length of stay [ Time Frame: 30 days after transplantation ]
    The number of days of hospital length of stay was calculated using the difference between the local date of discharge from the hospital and the date of hospital admission (day of surgery). If the patient died during surgery or prior to hospital discharge, the patient's date of death was recorded as the date of discharge.

  12. Occurence of acute rejection episode [ Time Frame: 30 days after transplantation ]
    An acute rejection episode defined as the grafted liver is attacked by the immune system.

  13. Survival up to 6 months [ Time Frame: 6 months after transplantation ]
    Survival was calculated from the date of participant initial transplant to the date of participant death due to any cause, within 6 months after the surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators will include all recipients of a liver transplant across five Canadian centres.
Criteria

Inclusion Criteria:

All consecutive adult liver transplant recipients in each center during a one-year period.

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732689


Contacts
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Contact: François-Martin Carrier, MD, FRCPC 514-890-8000 ext 12131 francois.martin.carrier@umontreal.ca
Contact: Eva Amzallag, M.Sc. eva.amzallag.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Contact: Eva Amzallag, M.Sc.       eva.amzallag.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
McGill University Health Centre/Research Institute of the McGill University Health Centre
Toronto General Hospital
London Health Sciences Centre
University of Alberta
Investigators
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Principal Investigator: François-Martin Carrier, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04732689    
Other Study ID Numbers: 20.353
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Liver Failure
Digestive System Diseases
Hepatic Insufficiency