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Clinical Trials/NCT02341833
NCT02341833
Unknown
Phase 4

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

University of Liege1 site in 1 country240 target enrollmentJanuary 2015

Overview

Phase
Phase 4
Intervention
Sevoflurane
Conditions
Post-transplantation Liver Allograft Function
Sponsor
University of Liege
Enrollment
240
Locations
1
Primary Endpoint
Composite outcome of liver function following liver transplantation.
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gregory Minguet

Doctor

University of Liege

Eligibility Criteria

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.

Arms & Interventions

Sevoflurane

1 MAC of sevoflurane for 15 minutes before organs procurement.

Intervention: Sevoflurane

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Study Sites (1)

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