Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts

January 20, 2015 updated by: Gregory Minguet, University of Liege
The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, B-4000
        • Department of Anesthesiology, CHU Liège

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility

Exclusion Criteria:

  • haemodynamic instability that precludes safe administration of 2% sevoflurane.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sevoflurane
1 MAC of sevoflurane for 15 minutes before organs procurement.
Drug: Sevoflurane
In the sevoflurane group, the anesthetic agent has to be administered immediately after arrival in the operating room to reach an end-expiratory target concentration of 2%. This concentration of sevoflurane should be maintained until the procedural cardiac arrest and for at least 15 min.
No Intervention: No intervention
No volatile anesthetics during organs procurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome of liver function following liver transplantation.
Time Frame: First week post-transplantation
  • Transaminases, bilirubin, prothrombin time (PT) and international normalized ratio (INR) on the first post-transplantation blood test and on the following samples from the 1st to the 7th postoperative days.

  • Number of liver recipients that will meet the criteria for "early allograft dysfunction" as defined by :

    • bilirubin ≥10 mg/dL on the 7th day.
    • INR ≥ 1.6 on the 7th day.
    • ALAT or ASAT > 2000 UI/L during the first 7 postoperative days.
First week post-transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
• Incidence of primary non function (liver failure requiring emergent re-transplantation)
Time Frame: 30-day and 6-month after transplantation.
30-day and 6-month after transplantation.
• Hospital length of stay.
Time Frame: 30-day and 6-month after transplantation.
30-day and 6-month after transplantation.
• Allograft function (yes/no) at 30-day and 6-month after transplantation.
Time Frame: 30-day and 6-month after transplantation.
30-day and 6-month after transplantation.
• Hospital mortality and at 30-day.
Time Frame: 30-day.
30-day.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome of post transplantation kidney function.
Time Frame: First week after transplantation, 30 day and 6-month.
• Creatinine on the first post-transplantation blood test and on the following samples from the first to the 7th postoperative days. Maximal creatinine values and values at 72-hour after transplantation, the time for 50% decline, and the area under the curve during the first postoperative week.
First week after transplantation, 30 day and 6-month.
• Delayed graft function : (defined as dialysis during first postop wk; decline in creatinine value
Time Frame: First week after transplantation, 30 day and 6-month.
  • Dialysis during the first postoperative week.
  • Decline in creatinine value of less than 10% per day during 3 consecutive days.
First week after transplantation, 30 day and 6-month.
• Length of delayed graft function.
Time Frame: First week after transplantation, 30 day and 6-month.
First week after transplantation, 30 day and 6-month.
• Primary non function (patient who must go back to chronic hemodialysis and must be listed for re-transplantation
Time Frame: First week after transplantation, 30 day and 6-month.
patient who must go back to chronic hemodialysis and must be listed for re-transplantation, at 30-day and 6-month after transplantation.
First week after transplantation, 30 day and 6-month.
• Hospital length of stay.
Time Frame: First week after transplantation, 30 day and 6-month.
First week after transplantation, 30 day and 6-month.
• Hospital mortality and mortality at 30-day.
Time Frame: First week after transplantation, 30 day and 6-month.
First week after transplantation, 30 day and 6-month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

  • Principal Investigator: Jean L Joris, MD, PhD, CHU Liège - Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 20, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-26-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-transplantation Liver Allograft Function

Clinical Trials on Sevoflurane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe