Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-01 @ 5:18 AM
Study NCT ID:
NCT03672812
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Liraglutide in Brain Death
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001926', 'term': 'Brain Death'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003128', 'term': 'Coma'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change inflammation', 'timeFrame': 'from 6 hours to 24 hours', 'description': 'change interleukin 6'}], 'secondaryOutcomes': [{'measure': 'change inflammation with liraglutide', 'timeFrame': 'from 6 to 24 hours', 'description': 'change interleukin 8'}, {'measure': 'change inflammation liraglutide group', 'timeFrame': 'from 6 to 24 hours', 'description': 'change interleukin 10'}, {'measure': 'change inflammation intervention group', 'timeFrame': 'from 6 to 24 hours', 'description': 'change tumor necrosis factor-alpha'}, {'measure': 'change inflammation', 'timeFrame': 'from 6 to 24 hours', 'description': 'change interferon gamma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liraglutide', 'brain death', 'inflammation'], 'conditions': ['Brain Death']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* individuals deceased more than 18 years after the end of the brain death protocol\n\nExclusion Criteria:\n\n* Pregnant women, patients with advanced renal failure on hemodialysis, with hepatic insufficiency or allergy known to liraglutide'}, 'identificationModule': {'nctId': 'NCT03672812', 'briefTitle': 'The Use of Liraglutide in Brain Death', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '87650318100005327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'placebo', 'description': '0,5ml'}, {'type': 'EXPERIMENTAL', 'label': 'liraglutide', 'description': '0,5ml', 'interventionNames': ['Drug: Liraglutide']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'liraglutide 3mg 6/6 hours', 'armGroupLabels': ['liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89010380', 'city': 'Blumenau', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Hospital Santa Isabel', 'geoPoint': {'lat': -26.91944, 'lon': -49.06611}}], 'overallOfficials': [{'name': 'Cristiane Leitao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clinicas de Porto Alegre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}