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NCT03672812 Clinical Trial

The Use of Liraglutide in Brain Death

Brain Death Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03672812
Other study ID # 87650318100005327
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 1, 2018
Est. completion date February 10, 2022

Study information
Verified date March 2024
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date February 10, 2022
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Liraglutide
liraglutide 3mg 6/6 hours

Locations
Country Name City State
Brazil Hospital Santa Isabel Blumenau Santa Catarina

Sponsors (1)
Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary change inflammation change interleukin 6 from 6 hours to 24 hours
Secondary change inflammation with liraglutide change interleukin 8 from 6 to 24 hours
Secondary change inflammation liraglutide group change interleukin 10 from 6 to 24 hours
Secondary change inflammation intervention group change tumor necrosis factor-alpha from 6 to 24 hours
Secondary change inflammation change interferon gamma from 6 to 24 hours
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