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The Use of Liraglutide in Brain Death

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Unknown status
CT.gov ID
NCT03672812
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
29.3
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Dec 10, 2019
Anticipated Study Completion Date :
Feb 10, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: placebo

0,5ml
Experimental: liraglutide

0,5ml

Drug: Liraglutide
liraglutide 3mg 6/6 hours
Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change inflammation [from 6 hours to 24 hours]

      change interleukin 6

    Secondary Outcome Measures

    1. change inflammation with liraglutide [from 6 to 24 hours]

      change interleukin 8

    2. change inflammation liraglutide group [from 6 to 24 hours]

      change interleukin 10

    3. change inflammation intervention group [from 6 to 24 hours]

      change tumor necrosis factor-alpha

    4. change inflammation [from 6 to 24 hours]

      change interferon gamma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Santa Isabel Blumenau Santa Catarina Brazil 89010380

    Sponsors and Collaborators

    • Hospital de Clinicas de Porto Alegre

    Investigators

    • Principal Investigator: Cristiane Leitao, PhD, Hospital de Clinicas de Porto Alegre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital de Clinicas de Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT03672812
    Other Study ID Numbers:
    • 87650318100005327
    First Posted:
    Sep 17, 2018
    Last Update Posted:
    Sep 28, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hospital de Clinicas de Porto Alegre
    liraglutide
    brain death
    inflammation
    Additional relevant MeSH terms:
    Brain Death
    Death
    Liraglutide

    Study Results

    No Results Posted as of Sep 28, 2018