Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 9:22 AM
Study NCT ID:
NCT01683006
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2012-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2012-04-08', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in resting energy expenditure between patients with favorable and unfavorable outcome', 'timeFrame': 'initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h', 'description': 'resting energy expenditure will be assessed with indirect calorimetry at different measurement time points:\n\n1. 12-24 h after initiation of mild hypothermia (33C°)\n2. during warming up (at 34.5°C)\n3. during warming up (at 36°C)\n4. during warming up (at 36.5°C - 37.5°C)\n5. normal Temperature, after 48 - 72 h after initiation of mild hypothermia'}, {'measure': 'Difference in substrate metabolism between patients with favorable and unfavorable outcome', 'timeFrame': 'initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h', 'description': 'substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points:\n\n1. 12-24 h after initiation of mild hypothermia (33C°)\n2. during warming up (at 34.5°C)\n3. during warming up (at 36°C)\n4. during warming up (at 36.5°C - 37.5°C)\n5. at normal Temperature, after 48 - 72 h after initiation of mild hypothermia'}], 'primaryOutcomes': [{'measure': 'Change of resting energy expenditure compared to baseline at 33C°', 'timeFrame': 'initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h', 'description': 'resting energy expenditure will be assessed with indirect calorimetry at different measurement time points:\n\n1. 12-24 h after initiation of mild hypothermia (33C°)\n2. during warming up (at 34.5°C)\n3. during warming up (at 36°C)\n4. during warming up (at 36.5°C - 37.5°C)\n5. normal Temperature, after 48 - 72 h after initiation of mild hypothermia'}], 'secondaryOutcomes': [{'measure': 'Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C°', 'timeFrame': 'initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h', 'description': 'substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points:\n\n1. 12-24 h after initiation of mild hypothermia (33C°)\n2. during warming up (at 34.5°C)\n3. during warming up (at 36°C)\n4. during warming up (at 36.5°C - 37.5°C)\n5. at normal Temperature, after 48 - 72 h after initiation of mild hypothermia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.', 'detailedDescription': 'Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering. However, neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolonged ICU stay. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, the advantages and disadvantages of neuromuscular blockers during therapeutic hypothermia need to be re-evaluated.\n\nAim of this study is to investigate if continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoiding an increase in energy expenditure in patients during therapeutic hypothermia and rewarming after cardiac arrest (initial 72h).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin\n\nExclusion Criteria:\n\n* age \\< 18\n* cardiac arrest \\>6 hours before admittance at the hospital\n* patients with known or clinically apparent pregnancy\n* patients who reach our hospital with a body temperature below 35°C\n* patients with known allergic reactions against rocuronium\n* patients with a history of myasthenia gravis\n* patients with obvious intoxication\n* wards of the state/prisoners\n* patients with known epileptic disease'}, 'identificationModule': {'nctId': 'NCT01683006', 'briefTitle': 'Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest', 'orgStudyIdInfo': {'id': '753/2009UH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neuromuscular blocker group', 'description': 'Continuous application of neuromuscular blockers during therapeutic hypothermia.\n\nBolus application of placebo in case of shivering.', 'interventionNames': ['Drug: Rocuronium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Continuous application of placebo during therapeutic hypothermia.\n\nBolus application of neuromuscular blockers in case of shivering.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rocuronium', 'type': 'DRUG', 'description': 'Continuous application of Rocuronium (0.5 mg/kg body weight/hour).\n\nBolus application of placebo in case of shivering.', 'armGroupLabels': ['Neuromuscular blocker group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Continuous application of placebo during therapeutic hypothermia.\n\nBolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Ulrike Holzinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Assoc Prof', 'investigatorFullName': 'Ulrike Holzinger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}