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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | No Intervention | 0,5ml | |
| liraglutide | Experimental | 0,5ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | liraglutide 3mg 6/6 hours |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change inflammation | change interleukin 6 | from 6 hours to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| change inflammation with liraglutide | change interleukin 8 | from 6 to 24 hours |
| change inflammation liraglutide group | change interleukin 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiane Leitao, PhD | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santa Isabel | Blumenau | Santa Catarina | 89010380 | Brazil |
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| ID | Term |
|---|---|
| D001926 | Brain Death |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| from 6 to 24 hours |
| change inflammation intervention group | change tumor necrosis factor-alpha | from 6 to 24 hours |
| change inflammation | change interferon gamma | from 6 to 24 hours |
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |