NCT02341833

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

2.9 years

First QC Date

June 26, 2014

Last Update Submit

January 20, 2015

Conditions

Post-transplantation Liver Allograft Function

Keywords

Anesthetic preconditioningSevofluraneLiver transplantationbrain-death donors

Outcome Measures

Primary Outcomes (1)

  • Composite outcome of liver function following liver 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 Outcomes (4)

  • • Incidence of primary non function (liver failure requiring emergent re-transplantation)

    30-day and 6-month after transplantation.

  • • Hospital length of stay.

    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 mortality and at 30-day.

    30-day.

Other Outcomes (6)

  • Composite outcome of post transplantation kidney function.

    First week after transplantation, 30 day and 6-month.

  • • Delayed graft function : (defined as dialysis during first postop wk; decline in creatinine value

    First week after transplantation, 30 day and 6-month.

  • • Length of delayed graft function.

    First week after transplantation, 30 day and 6-month.

  • +3 more other outcomes

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

1 MAC of sevoflurane for 15 minutes before organs procurement.

Drug: Sevoflurane

No intervention

NO INTERVENTION

No volatile anesthetics during organs procurement

Interventions

SevofluraneDRUG

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.

Sevoflurane

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, CHU Liège

Liège, B-4000, Belgium

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Jean L Joris, MD, PhD

    CHU Liège - Belgium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean L Joris, MD, PhD

CONTACT

32-4-3667180jean.joris@chu.ulg.ac.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 26, 2014

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

BE(1)