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

Phase 4

• Conditions: Post-transplantation Liver Allograft Function
• Interventions: Drug: Sevoflurane

• Registration Number: NCT02341833
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-26
• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-19
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-21
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	1 MAC of sevoflurane for 15 minutes before organs procurement.

Primary Outcome Measures

Name	Time	Method
Composite outcome of liver function following liver transplantation.	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 Outcome Measures

Name	Time	Method
• 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.

Trial Locations

Locations (1)

Department of Anesthesiology, CHU Liège; 🇧🇪 Liège, Belgium