Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-31 @ 6:16 AM
Study NCT ID:
NCT06744361
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 282}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuron-specific enolase (NSE) measured 48 hours after OHCA', 'timeFrame': '48 hours after OHCA', 'description': 'To determine the neuroprotective efficacy of ketamine compared with propofol administered as part of sedation for intubation after initial resuscitation from OHCA'}], 'secondaryOutcomes': [{'measure': 'Death from any cause', 'timeFrame': '180 days after cardiac arrest', 'description': 'Death from any cause 180 days after cardiac arrest'}, {'measure': 'Neurological outcome: modified Rankin Score (mRS)', 'timeFrame': 'At 2 weeks (at discharge)', 'description': 'Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.'}, {'measure': 'Neurological outcome: Cerebral Performance Categories (CPC)', 'timeFrame': 'At 2 weeks (at discharge)', 'description': 'Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).'}, {'measure': 'Neurological outcome: modified Rankin Score (mRS)', 'timeFrame': 'At 180 days after OHCA.', 'description': 'Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.'}, {'measure': 'Neurological outcome: modified Rankin Score (mRS)', 'timeFrame': 'At 240 days after OHCA.', 'description': 'Neurological outcome by and modified Rankin Score (mRS). Meassured from 0 to 6, where 0 is no symptoms.'}, {'measure': 'Neurological outcome: Cerebral Performance Categories (CPC)', 'timeFrame': 'At 180 days after OHCA.', 'description': 'Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).'}, {'measure': 'Neurological outcome: Cerebral Performance Categories (CPC)', 'timeFrame': 'At 240 days after OHCA.', 'description': 'Neurological outcome by Cerebral Performance Categories (CPC) meassured fra 1-5 (a score of 1 is normal/good cerebral function).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Out-of-hospital Cardiac Arrest (OHCA)']}, 'descriptionModule': {'briefSummary': 'OHCA is a critical medical emergency with significant mortality and morbidity primarily due to hypoxic-ischemic brain injury (HIBI). Despite advances in resuscitation techniques, the neurological outcomes for survivors remain poor. Current post-resuscitation practices lack specific neuroprotective strategies. Ketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, has shown potential neuroprotective properties in preclinical and clinical studies due to its ability to inhibit excitotoxicity and reduce neuronal apoptosis. This trial hypothesizes that ketamine, when used for sedation in OHCA patients, may offer superior neuroprotective benefits compared to the commonly used sedative propofol. By comparing the effects of ketamine and propofol on neuronal damage markers and long-term neurological outcomes, this study aims to identify a potentially effective intervention to improve the prognosis of OHCA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age ≥18 years) AND\n* resuscitated OHCA of presumed cardiac cause with a shockable first recorded heart rhythm AND\n* mean arterial pressure (MAP) \\>40 mmHg AND\n* a decision to perform prehospital intubation.\n\nExclusion Criteria:\n\n* Advanced life support termination-of-resuscitation (TOR) criteria met\n* Systolic blood pressure \\>190 mmHg\n* Known allergy to ketamine or propofol\n* Chronic diseases making 180-day survival unlikely\n* Body temperature \\<30° C.'}, 'identificationModule': {'nctId': 'NCT06744361', 'acronym': 'KETOHCA', 'briefTitle': 'Ketamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'KETamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (OHCA) - the KETOHCA Trial', 'orgStudyIdInfo': {'id': '2024-515987-29-00'}, 'secondaryIdInfos': [{'id': '2024-515987-29-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-ketamin', 'description': 'Intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine', 'interventionNames': ['Drug: esketamine hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Prehospital intravenous or intraosseous bolus administration of a minimum dose of 0.25 mg/kg propofol', 'interventionNames': ['Drug: propofol']}], 'interventions': [{'name': 'esketamine hydrochloride', 'type': 'DRUG', 'description': 'Prehospital intravenous or intraosseous bolus administration at a minimum of 0.5 mg/kg of esketamine', 'armGroupLabels': ['S-ketamin']}, {'name': 'propofol', 'type': 'DRUG', 'description': 'Prehospital intravenous or intraosseous bolus administration at a minimum dose of 0.25 mg/kg propofol', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Laust R Obling, MD', 'role': 'CONTACT', 'email': 'laust.obling.01@regionh.dk', 'phone': '+4520404577'}, {'name': 'Laust R Obling, MD', 'role': 'CONTACT'}, {'name': 'Salma Charabi, MD', 'role': 'CONTACT'}], 'facility': 'Department of Cardiology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense C', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Henrik Schmidt, MD', 'role': 'CONTACT', 'email': 'henrik.schmidt@rsyd.dk', 'phone': '+4529647253'}, {'name': 'Henrik Schmidt, MD', 'role': 'CONTACT'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'centralContacts': [{'name': 'Salma Charabi, MD', 'role': 'CONTACT', 'email': 'salma.charabi@regionh.dk', 'phone': '35450572'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christian Hassager', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Christian Hassager', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}