The Use of Liraglutide in Brain Death

Study Overview
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Brief Summary
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There is evidence of the association of brain death and inflammation, affecting outcomes of transplanted organs, but in a way not fully understood. Observational studies suggest that the use of target-guided therapies has a beneficial effect in reducing the rate of donor loss due to cardiac arrest and increasing the rate of donor-picked organs, which will be tested through the randomized clinical trial. However, no study so far has directly tested the effect of drugs with anti-inflammatory and anti-apoptotic properties administered to the donor in encephalic death in reducing inflammation of organs to be transplanted. This study aims to evaluate the use of liraglutide in patients with brain death in relation to their ability to attenuate the inflammation induced by encephalic death by means of a randomized clinical trial.

Detailed Description
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The intervention group will be composed of individuals deceased in brain dead, after the conclusion of the brain dead protocol by the teams responsible for the Intensive care and will receive liraglutide. The control group will be composed of the same population of individuals who died in brain dead of the intervention group, but will receive a placebo.

Official Title
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Randomized Clinical Trial to Evaluate the Use of Liraglutide in Individuals With Brain Death and Anti-inflammatory and Anti-apoptotic Effects on Organs to be Transplanted

Conditions
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Brain Death

Intervention / Treatment
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* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals deceased more than 18 years after the end of the brain death protocol Exclusion Criteria: Pregnant women, patients with advanced renal failure on hemodialysis, with hepatic insufficiency or allergy known to liraglutide

Ages Eligible for Study
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Minimum Age: 18 Years

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: placebo<br>0,5ml | |
| Experimental: liraglutide<br>0,5ml | Drug: Liraglutide<br>* liraglutide 3mg 6/6 hours<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change inflammation | change interleukin 6 | from 6 hours to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change inflammation with liraglutide | change interleukin 8 | from 6 to 24 hours | 
| change inflammation liraglutide group | change interleukin 10 | from 6 to 24 hours | 
| change inflammation intervention group | change tumor necrosis factor-alpha | from 6 to 24 hours | 
| change inflammation | change interferon gamma | from 6 to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liraglutide, brain death, inflammation