Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-22 @ 2:02 PM
Study NCT ID:
NCT06156059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Bedtime Melatonin in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'id': 'D000083244', 'term': 'Thrombotic Stroke'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Indistinguishable oral suspension or capsule'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blind randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2023-11-26', 'studyFirstSubmitQcDate': '2023-11-26', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality at 90 days', 'timeFrame': 'Inclusion to 90 days', 'description': 'All-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Shock', 'Stroke Hemorrhagic', 'Strokes Thrombotic', 'Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Oxidative stress is one of the main mechanisms causing harm in severe infection with septic shock, ischemia-reperfusion injury in resuscitated cardiac arrest and ischemic and hemorrhagic stroke.\n\nMelatonin is a potent scavenger of the mediators of oxidative stress, oxygen and nitrogen-reactive species, which directly injure cell structures like walls and DNA and thus cause organ dysfunction.\n\nIn a previous study we have observed that high-dose oral bedtime melatonin (OBM) is associated with improved organ function in severe Covid-19 patients', 'detailedDescription': 'This is a double-blind randomized, adaptive trial in the 4 indications mentioned above giving 100 mg of OBM or placebo.\n\nInterim analyses with pre-specified stopping rules will be performed in each sub-study for specific outcome variables collected at scheduled timelines.\n\nComparative organ dysfunction score (Sequential Organ Failure Evaluation-SOFA) will be done at baseline, 7, 14, and 30 days and mortality evaluated at 30 and 90 days.\n\nFor the 3 study groups enrolling stroke and resuscitated cardiac arrest patients, the modified Rankin score and the CVC (Glasgow) at 30 and 90 days will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU stay \\>5 days\n\nExclusion Criteria:\n\n* ominous prognosis'}, 'identificationModule': {'nctId': 'NCT06156059', 'acronym': 'Mel-ICU', 'briefTitle': 'Oral Bedtime Melatonin in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': 'Oral Bedtime Melatonin in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'Mel-ICU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Septic Shock Standard of Care (SOC)', 'description': 'Placebo suspension and capsules', 'interventionNames': ['Drug: Placebo suspension or capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Septic shock Oral Bedtime Melatonin (OBM)', 'description': '100 mg suspension or in capsules OBM', 'interventionNames': ['Drug: Oral Bedtime Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Resuscitated Cardiorespiratory Arrest SOC', 'description': 'Placebo suspension and capsules', 'interventionNames': ['Drug: Placebo suspension or capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resuscitated Cardiorespiratory Arrest OBM', 'description': '100 mg suspension or in capsules OBM', 'interventionNames': ['Drug: Oral Bedtime Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ischemic Stroke (SOC)', 'description': 'Placebo suspension and capsules', 'interventionNames': ['Drug: Placebo suspension or capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ischemic stroke (OBM)', 'description': '100 mg suspension or in capsules OBM', 'interventionNames': ['Drug: Oral Bedtime Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Hemorraghic stroke (SOC)', 'description': 'Placebo suspension and capsules', 'interventionNames': ['Drug: Placebo suspension or capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hemorrhagic stroke (OBM)', 'description': '100 mg suspension or in capsules OBM', 'interventionNames': ['Drug: Oral Bedtime Melatonin']}], 'interventions': [{'name': 'Oral Bedtime Melatonin', 'type': 'DRUG', 'otherNames': ['Oral melatonin'], 'description': '100 mg oral suspension or capsule given at bedtime', 'armGroupLabels': ['Hemorrhagic stroke (OBM)', 'Ischemic stroke (OBM)', 'Resuscitated Cardiorespiratory Arrest OBM', 'Septic shock Oral Bedtime Melatonin (OBM)']}, {'name': 'Placebo suspension or capsule', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Indistinguishable suspension or capsule', 'armGroupLabels': ['Hemorraghic stroke (SOC)', 'Ischemic Stroke (SOC)', 'Resuscitated Cardiorespiratory Arrest SOC', 'Septic Shock Standard of Care (SOC)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Critical Care Department', 'investigatorFullName': 'Miguel Sanchez Garcia', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}}