Back to resultsThe Use of Liraglutide in Brain Death
Primary Purpose
Brain Death
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Brain Death focused on measuring liraglutide, brain death, inflammation
Eligibility Criteria
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
Sites / Locations
- Hospital Santa IsabelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
placebo
liraglutide
Arm Description
0,5ml
0,5ml
Outcomes
Primary Outcome Measures
change inflammation
change interleukin 6
Secondary Outcome Measures
change inflammation with liraglutide
change interleukin 8
change inflammation liraglutide group
change interleukin 10
change inflammation intervention group
change tumor necrosis factor-alpha
change inflammation
change interferon gamma
Full Information
NCT ID
NCT03672812
First Posted
September 13, 2018
Last Updated
September 27, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03672812
Brief Title
The Use of Liraglutide in Brain Death
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Anticipated)
Study Completion Date
February 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death
Keywords
liraglutide, brain death, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
No Intervention
Arm Description
0,5ml
Arm Title
liraglutide
Arm Type
Experimental
Arm Description
0,5ml
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
placebo
Intervention Description
liraglutide 3mg 6/6 hours
Primary Outcome Measure Information:
Title
change inflammation
Description
change interleukin 6
Time Frame
from 6 hours to 24 hours
Secondary Outcome Measure Information:
Title
change inflammation with liraglutide
Description
change interleukin 8
Time Frame
from 6 to 24 hours
Title
change inflammation liraglutide group
Description
change interleukin 10
Time Frame
from 6 to 24 hours
Title
change inflammation intervention group
Description
change tumor necrosis factor-alpha
Time Frame
from 6 to 24 hours
Title
change inflammation
Description
change interferon gamma
Time Frame
from 6 to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiane Leitao, PhD
Phone
51 99655618
Email
crisbleitao@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Rech, PhD
Phone
51 99593669
Email
threch@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane Leitao, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Santa Isabel
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010380
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geisiane Custodio, Master
Phone
47 991335153
Email
geisiane_c@yahoo.com.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Use of Liraglutide in Brain Death
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