The Use of Liraglutide in Brain Death

NCT03672812 | Completed Phase 3

• 1 other identifier: 87650318100005327
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Death

Keywords

liraglutide; brain death; inflammation

Outcome Measures

Primary Outcomes (1)

• change inflammation

  change interleukin 6

  from 6 hours to 24 hours

Secondary Outcomes (4)

• change inflammation with liraglutide

  from 6 to 24 hours

• change inflammation liraglutide group

  from 6 to 24 hours

• change inflammation intervention group

  from 6 to 24 hours

• change inflammation

  from 6 to 24 hours

Study Arms (2)

placebo

NO INTERVENTION

0,5ml

liraglutide

EXPERIMENTAL

0,5ml

Drug: Liraglutide

Interventions

Liraglutide DRUG

liraglutide 3mg 6/6 hours

Also known as: placebo

liraglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital Santa Isabel

Blumenau, Santa Catarina, 89010380, Brazil

Location

MeSH Terms

Conditions

Brain Death; Inflammation

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Cristiane Leitao, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: September 1, 2018
• Primary Completion: December 10, 2019
• Study Completion: February 10, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

BR (1)