Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT03407404
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2017-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Drugs will be premixed and coded for ketamine-midazolam or morphine-midazolam. The colorless drug mixture shall be provided to the attending physician to start the infusion at 2ml/hour and to be titrated to the desired level of sedation.\n\nThe investigator and participant will be unaware of which group a certain patient is under.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to either receive ketamine-midazolam or morphine-midazolam for continous sedation at enrollment, then followed up for outcomes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'whyStopped': 'Futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2017-06-05', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of mechanical ventilation', 'timeFrame': '14 days', 'description': 'in hours from start of mechanical ventialtion'}, {'measure': 'incidence of hypotension', 'timeFrame': '14 days', 'description': 'incidence of hypotension requiring vasopressor support.'}, {'measure': 'incidence of delirium', 'timeFrame': '14 days', 'description': 'assessed daily with the CAM-ICU score'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': '14 days', 'description': 'length of stay in the intensive care unit from enrollment.'}, {'measure': 'mortality rate', 'timeFrame': 'within 14 days', 'description': 'number of deaths in each study arm'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'A prospective, double-blinded, multicenter randomized control trial. All critically ill patients above 12 years of age requiring continuous sedation for \\>24hrs in the ICU will be screened and those meeting selection criteria (and consented) will be enrolled into the study.\n\n.', 'detailedDescription': '165 participants shall be consecutively randomized into either sedation with ketamine-midazolam or morphine-midazolam group using a block sequence technique; group concealed in brown envelopes. Blinding will be at patient/next of kin level as well as investigator/data collector level.\n\nEnrolled subjects shall be followed up for treatment history, co-morbidities and related data will be collected, results analyzed and study findings will be availed to ICU physicians and Ministry of health to guide treatment considerations and for health care planning.\n\nData shall be collected using a standardized questionnaire by trained research assistants. It will be double entered into Epidata and exported to STATA version 12.0 for analysis. Continuous variables will be expressed as means and standard deviations, while categorical data will be expressed as frequencies with their respective percentages. Linear regression and logistic regression used to analyse primary outcomes, as well as multivariate analysis to detect associations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>12years of age.\n2. Anticipated need for sedation for \\>24hours.\n\nExclusion Criteria:\n\n1. Hypertensive crisis i.e. sustained SBP \\>200mmHg/DBP\\>110mmHg\n2. Status epilepticus\n3. Ischemic heart disease and severe LV dysfunction\n4. Persistent tachyarrythmias\n5. History of mental illness\n6. Hypersensitivity to ketamine, morphine or midazolam.\n7. Tetanus -due to the muscle rigidity that may be caused by ketamine. Reasons for exclusions 1 to 4; Ketamine stimulates the sympathetic nervous system causing transient increase in myocardial work and blood pressure and has psychoactive effects'}, 'identificationModule': {'nctId': 'NCT03407404', 'acronym': 'KeMiMof', 'briefTitle': 'Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': '2015/HD07/1275U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine-midazolam', 'description': 'Continous intravenous sedation with a colorless drug mixture in 50ml syringe containing 900mg ketamine and 36mg midazolam.', 'interventionNames': ['Combination Product: Ketamine-Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine-Midazolam', 'description': 'Continous intravenous sedation with a colourless drug mixture in 50ml syringes containing 54mg morphine and 36mg midazolam.', 'interventionNames': ['Combination Product: Morphine -Midazolam']}], 'interventions': [{'name': 'Ketamine-Midazolam', 'type': 'COMBINATION_PRODUCT', 'description': 'Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.', 'armGroupLabels': ['Ketamine-midazolam']}, {'name': 'Morphine -Midazolam', 'type': 'COMBINATION_PRODUCT', 'description': 'Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.', 'armGroupLabels': ['Morphine-Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '256', 'city': 'Kampala', 'state': 'Central Region', 'country': 'Uganda', 'facility': 'Mulago National Referral Hospital ICU', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Christine Namata, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'THRiVE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}