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NCT Number: NCT03672812

The Use of Liraglutide in Brain Death

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.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Inflammation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Santa Isabel

Blumenau, Santa Catarina, 89010380, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

liraglutide 3mg 6/6 hours

Other names: placebo

Primary outcomes

  1. change inflammation

    Time frame: from 6 hours to 24 hours

    change interleukin 6

Secondary outcomes

  1. change inflammation with liraglutide

    Time frame: from 6 to 24 hours

    change interleukin 8

  2. change inflammation liraglutide group

    Time frame: from 6 to 24 hours

    change interleukin 10

  3. change inflammation intervention group

    Time frame: from 6 to 24 hours

    change tumor necrosis factor-alpha

  4. change inflammation

    Time frame: from 6 to 24 hours

    change interferon gamma

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Sep 17, 2018
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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