Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-27 @ 4:58 PM
Study NCT ID:
NCT01083069
Status:
UNKNOWN
Last Update Posted:
2010-03-09
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-08', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological outcome after 6 month after MIH, Quality of life-survey', 'timeFrame': '6 Month', 'description': 'Neurological outcome after 6 month after MIH measured by questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Managing daily activities', 'timeFrame': '6 Month', 'description': 'Managing daily activities after 6 month after tMIH measured with a questionnaire.'}, {'measure': 'Surviving after hospitalization', 'timeFrame': '6 Month', 'description': 'Surviving after hospitalization after MIH'}, {'measure': 'Neurological outcome depending of the beginning of MIH', 'timeFrame': '6 month', 'description': 'Neurological outcome depending of the beginning of MIH'}, {'measure': 'Neurological Outcome in consideration of the practice of the treating instances.', 'timeFrame': '6 month', 'description': 'Neurological outcome in consideration of the practice of the treating instances after restoration of spontanous circulation measured with a questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sudden cardiac arrest', 'hypothermia', 'neurological outcome'], 'conditions': ['Cardiac Arrest', 'Hypothermia']}, 'descriptionModule': {'briefSummary': 'Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.', 'detailedDescription': 'Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after restoration of spontaneous circulation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* survived cardiac arrest\n* voluntary consent\n\nExclusion Criteria:\n\n* no voluntary consent'}, 'identificationModule': {'nctId': 'NCT01083069', 'briefTitle': 'Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation', 'orgStudyIdInfo': {'id': 'Cool-Trial Follow up'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COOL', 'description': 'Patients after therapy with mild hypothermia'}, {'label': 'UnCool', 'description': 'Patients without therapy with mild hypothermia due to non-operational cooling-devices'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Undine Pittl, MD', 'role': 'CONTACT', 'email': 'undine.pittl@gmail.com', 'phone': '0049-341-8651427'}, {'name': 'Holger Thiele, Associate Professor', 'role': 'CONTACT', 'email': 'thielh@med.uni-leipzig.de', 'phone': '0049-341-8651427'}, {'name': 'Holger Thiele, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Undine Pittl, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Leipzig, Heart Center, Cardiology', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Undine Pittl, MD', 'role': 'CONTACT', 'email': 'undine.pittl@gmail.com', 'phone': '0049-341-8651427'}, {'name': 'Holger Thiele, Associate Professor', 'role': 'CONTACT', 'email': 'thielh@med.uni-leipzig.de', 'phone': '0049-341-8651427'}], 'overallOfficials': [{'name': 'Holger Thiele, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Chair'}, {'name': 'Undine Pittl, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Study Sub-invesigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Holger Thiele, Associate Professor Study Chair', 'oldOrganization': 'University of Leipzig, Heart center'}}}}