The Use of Liraglutide in Brain Death

Phase 3

Completed

• Conditions: Brain Death
• Interventions: Drug: Liraglutide

• Registration Number: NCT03672812
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Primary Completion: 2019-12-10
• Study Completion: 2022-02-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• individuals deceased more than 18 years after the end of the brain death protocol

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Exclusion Criteria

• Pregnant women, patients with advanced renal failure on hemodialysis, with hepatic insufficiency or allergy known to liraglutide

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
liraglutide	Liraglutide	0,5ml

Primary Outcome Measures

Name	Time	Method
change inflammation	from 6 hours to 24 hours	change interleukin 6

Secondary Outcome Measures

Name	Time	Method
change inflammation with liraglutide	from 6 to 24 hours	change interleukin 8
change inflammation liraglutide group	from 6 to 24 hours	change interleukin 10
change inflammation intervention group	from 6 to 24 hours	change tumor necrosis factor-alpha
change inflammation	from 6 to 24 hours	change interferon gamma

Trial Locations

Locations (1)

Hospital Santa Isabel; 🇧🇷 Blumenau, Santa Catarina, Brazil