Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 5:17 AM
Study NCT ID:
NCT00888966
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2009-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxidative Stress and Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2009-04-25', 'studyFirstSubmitQcDate': '2009-04-25', 'lastUpdatePostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative stress markers and antioxidants after out of hospital cardiac arrest', 'timeFrame': '4 days'}], 'secondaryOutcomes': [{'measure': 'Lactate after out of hospital cardiac arrest', 'timeFrame': '4 days'}, {'measure': 'Outcome after out of hospital cardiac arrest', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart arrest', 'oxidative stress', 'lactic acid', 'outcome'], 'conditions': ['Heart Arrest']}, 'descriptionModule': {'briefSummary': 'Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.\n\nCardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.\n\nThe aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Out of hospital cardiac arrest\n\nExclusion Criteria:\n\n* refractory shock\n* moribund patient\n* resuscitation \\> 60 minutes\n* hypothermia \\< 30 degrees'}, 'identificationModule': {'nctId': 'NCT00888966', 'briefTitle': 'Oxidative Stress and Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': "Institut d'Anesthesiologie des Alpes Maritimes"}, 'officialTitle': 'Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia', 'orgStudyIdInfo': {'id': 'IAAM 2009-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Out of hospital cardiac arrest', 'description': 'Out of hospital cardiac patients successfully resuscitated and admitted to ICU'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06003', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Carole Ichai, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut d'Anesthesiologie des Alpes Maritimes", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Orban MD', 'oldOrganization': 'CHU de Nice'}}}}