The Use of Liraglutide in Brain Death

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03672812

Enrollment

Registered

2018-09-17

Start date

2018-09-01

Completion date

2022-02-10

Last updated

2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death

Keywords

liraglutide, brain death, inflammation

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.

Interventions

DRUGLiraglutide

liraglutide 3mg 6/6 hours

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change inflammation	from 6 hours to 24 hours	change interleukin 6

Secondary

Measure	Time frame	Description
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026