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

Study Overview
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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.

Conditions
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Post-transplantation Liver Allograft Function

Intervention / Treatment
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* Drug: Sevoflurane


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>1 MAC of sevoflurane for 15 minutes before organs procurement. | Drug: Sevoflurane<br>* 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.<br>|
| No Intervention: No intervention<br>No volatile anesthetics during organs procurement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetic preconditioning, Sevoflurane, Liver transplantation, brain-death donors