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CompletedNCT03672812Updated Mar 5, 2024

The Use of Liraglutide in Brain Death

A Phase 3 interventional study of Liraglutide in Brain Death, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by Hospital de Clinicas de Porto Alegre · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Brain Death

Keywords

  • liraglutide
  • brain death
  • inflammation
03

In context

Brain Death

74 studies on the registry are indexed under Brain Death; 10 are open to participants now.

This study's enrollment of 50 is below the median of 154 across 39 interventional studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women, patients with advanced renal failure on hemodialysis, with hepatic insufficiency or allergy known to liraglutide
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • No intervention
    placebo

    0,5ml

  • Experimental
    liraglutide

    0,5ml

    Drug: Liraglutide

Interventions

  • liraglutide 3mg 6/6 hours

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. change inflammation

    change interleukin 6

    Time frame: from 6 hours to 24 hours

Secondary outcomes

  1. change inflammation with liraglutide

    change interleukin 8

    Time frame: from 6 to 24 hours

  2. change inflammation liraglutide group

    change interleukin 10

    Time frame: from 6 to 24 hours

  3. change inflammation intervention group

    change tumor necrosis factor-alpha

    Time frame: from 6 to 24 hours

  4. change inflammation

    change interferon gamma

    Time frame: from 6 to 24 hours

07

Study locations

1 site
  • Hospital Santa Isabel
    Blumenau, Santa Catarina 89010380, Brazil
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03672812
Responsible party
Sponsor
First posted
Sep 17, 2018
Start date
Sep 1, 2018
Primary completion
Dec 10, 2019
Completion
Feb 10, 2022
Last update
Mar 5, 2024

Study contacts

Cristiane Leitao, PhD
principal investigator · Hospital de Clinicas de Porto Alegre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Liraglutide

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