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

NCT ID: NCT02341833

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

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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

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Conditions

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Post-transplantation Liver Allograft Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sevoflurane

1 MAC of sevoflurane for 15 minutes before organs procurement.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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 volatile anesthetics during organs procurement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Gregory Minguet

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean L Joris, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Liège - Belgium

Locations

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Department of Anesthesiology, CHU Liège

Liège, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Jean L Joris, MD, PhD

Role: CONTACT

32-4-3667180

Facility Contacts

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Jean L Joris, MD, PhD

Role: primary

32-4-3667180

Other Identifiers

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2014-26-06

Identifier Type: -

Identifier Source: org_study_id

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