Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 2:47 AM
Study NCT ID:
NCT04219735
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2019-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Minocycline on Delirium Incidence in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003128', 'term': 'Coma'}, {'id': 'C562573', 'term': 'cyclopia sequence'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo capsules looking identical to minocycline capsules'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo vs minocycline'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-26', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2020-01-03', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium and subsyndromal delirium incidence during ICU stay', 'timeFrame': 'up to 28 days', 'description': 'Number of patients with delirium'}], 'secondaryOutcomes': [{'measure': 'Days in delirium during ICU stay', 'timeFrame': 'up to 28 days', 'description': 'Number of days being in delirium'}, {'measure': 'Coma-delirium free days during ICU stay', 'timeFrame': 'up to 28 days', 'description': 'Number of days free of coma or delirium'}, {'measure': 'Length of mechanical ventilation during ICU stay', 'timeFrame': 'up to 28 days', 'description': 'Number of days in mechanical ventilation'}, {'measure': 'Length of ICU stay', 'timeFrame': 'up to 28 days', 'description': 'Number of days in the ICU'}, {'measure': 'ICU mortality', 'timeFrame': 'up to 28 days', 'description': 'Number of dead during ICU stay'}, {'measure': 'Hospital mortality', 'timeFrame': 'up to 90 days', 'description': 'Number of dead during hospital stay'}, {'measure': 'Long-term quality of life measured by the 12-Item Short-Form Health Survey V2', 'timeFrame': 'until 12 months after hospital discharge', 'description': 'Quality of life measured after hospital discharge'}, {'measure': 'Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score', 'timeFrame': 'until 12 months after hospital discharge', 'description': 'Cognitive function after hospital discharge'}, {'measure': 'Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B', 'timeFrame': 'At Day 1 and 3 of ICU stay, and hospital discharge', 'description': 'Inflammatory and brain derived plasma biomarker levels'}, {'measure': 'Long-term Post-Traumatic Stress Disorder measured by Impact of Event Scale-Revised', 'timeFrame': 'until 12 months after hospital discharge', 'description': 'Post-Traumatic Stress Disorder symptoms after hospital discharge measured by the Impact of Event Scale-Revised ranging from 0 to 88, higher values indicate more severe symptoms'}, {'measure': 'Long-term depression and anxiety symptoms measured by Hospital Anxiety and Depression Scale', 'timeFrame': 'until 12 months after hospital discharge', 'description': 'Depression and anxiety symptoms after hospital discharge measured by Hospital Anxiety and Depression Scale, ranging from 0 to 21, higher values indicate more severe symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['delirium', 'minocycline', 'intensive care unit'], 'conditions': ['Delirium', 'Coma']}, 'referencesModule': {'references': [{'pmid': '38043911', 'type': 'DERIVED', 'citation': 'Dal-Pizzol F, Coelho A, Simon CS, Michels M, Corneo E, Jeremias A, Damasio D, Ritter C. Prophylactic Minocycline for Delirium in Critically Ill Patients: A Randomized Controlled Trial. Chest. 2024 May;165(5):1129-1138. doi: 10.1016/j.chest.2023.11.041. Epub 2023 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'Delirium is a disorder of consciousness characterized by an acute onset and fluctuating course of impaired cognitive functioning. It is associated with unfavorable outcomes in hospitalized patients, including longer hospital length of stay, need for subsequent institutionalization and higher mortality rates. Patients in the intensive care unit (ICU) under mechanical ventilation and older age are at higher risk for the development of delirium. Several studies suggest that minocycline, through its anti-inflammatory effect, was able to prevent neuronal dysfunction in different models of ICU-related diseases. Thus, the present study aimed to evaluate the effect of minocycline on delirium development in critically ill patients. Patients will be randomized into one of two groups: the intervention group that will receive 100mg of minocycline 2 times a day and the placebo group. Medication or placebo will be continued for 28 days or until ICU discharge (whichever occurs first). Delirium will be diagnosed by the CAM-ICU. Coma will be defined by the Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 and biomarkers will be used as alternative outcomes related to the pathophysiology of the disease (IL-1, IL-6, IL-10, and BDNF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical or surgical patients,\n* Over 18 years,\n* Expected ICU stay of at least 2 days estimated by the attending intensivist,\n* Agree to participate in the study\n\nExclusion Criteria:\n\n* Delirium prior to inclusion,\n* Diagnosis of Parkinson's disease\n* Diagnosis of dementia,\n* Alcohol abuse history,\n* Acute neurological condition at admission\n* History of psychiatric disease\n* Use of antipsychotics\n* Pregnant or breastfeeding women,\n* Expectation of death within 2 days\n* Hospitalized for exclusive palliative care\n* Known allergy to minocycline"}, 'identificationModule': {'nctId': 'NCT04219735', 'briefTitle': 'Effect of Minocycline on Delirium Incidence in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude'}, 'officialTitle': 'Effect of Minocycline on Delirium Incidence in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'MinoDelirium'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minocycline', 'description': 'Minocycline 100 mg BID', 'interventionNames': ['Drug: Minocycline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules identical to experimental arm', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Minocycline', 'type': 'DRUG', 'description': 'Minocycline 100mg BID', 'armGroupLabels': ['Minocycline']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88801250', 'city': 'Criciúma', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'São José Hospital', 'geoPoint': {'lat': -28.6775, 'lon': -49.36972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Intensive Care Unit, São José Hospital. Head, Pathophysiology Laboratory, Universidade do Extremo Sul Catarinense', 'investigatorFullName': 'Felipe Dal Pizzol', 'investigatorAffiliation': 'Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude'}}}}