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The Use of Liraglutide in Brain Death

H

Hospital de Clinicas de Porto Alegre

Status and phase

Completed
Phase 3

Conditions

Brain Death

Treatments

Drug: Liraglutide

Study type

Interventional

Funder types

Other

Identifiers

NCT03672812
87650318100005327

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

50 participants in 2 patient groups

placebo
No Intervention group
Description:
0,5ml
liraglutide
Experimental group
Description:
0,5ml
Treatment:
Drug: Liraglutide

Trial contacts and locations

1

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Central trial contact

Cristiane Leitao, PhD; Tatiana Rech, PhD

Data sourced from clinicaltrials.gov

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