Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-11 @ 9:52 AM
Study NCT ID:
NCT00791050
Status:
UNKNOWN
Last Update Posted:
2008-11-14
First Post:
2008-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examine the Effects of Maintaining Body Core Temperature During CABGs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-11-13', 'studyFirstSubmitDate': '2008-11-13', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of atrial fibrillation', 'timeFrame': 'First 48 postoperative hours'}, {'measure': 'Rate of acute renal failure', 'timeFrame': 'First 48 postoperative hours'}], 'secondaryOutcomes': [{'measure': 'Rate of Myocardial infarction and low output syndrome', 'timeFrame': 'First postoperative 48 hours'}, {'measure': 'Rate of Type I neurological injury', 'timeFrame': 'First 48 postoperative hours'}, {'measure': 'Total units of RBCs transfused', 'timeFrame': 'First 48 postoperative hours'}, {'measure': 'Length of mechanical ventilation', 'timeFrame': 'First 48 postoperative hours'}, {'measure': 'Rate of in-hospital mortality', 'timeFrame': '30 postoperative days'}, {'measure': 'Intensive Care Unit length of stay', 'timeFrame': '30 postoperative days'}, {'measure': 'Hospital length of stay', 'timeFrame': '30 postoperative days'}, {'measure': 'Cardiac Troponin I (cTnI) curve', 'timeFrame': 'First postoperative 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypothermia/complications/etiology', 'coronary artery bypass/adverse effects'], 'conditions': ['Anesthesia', 'Hypothermia', 'Coronary Artery Bypass Grafting']}, 'referencesModule': {'references': [{'pmid': '12538173', 'type': 'BACKGROUND', 'citation': 'Nesher N, Zisman E, Wolf T, Sharony R, Bolotin G, David M, Uretzky G, Pizov R. Strict thermoregulation attenuates myocardial injury during coronary artery bypass graft surgery as reflected by reduced levels of cardiac-specific troponin I. Anesth Analg. 2003 Feb;96(2):328-35, table of contents. doi: 10.1097/00000539-200302000-00007.'}]}, 'descriptionModule': {'briefSummary': 'Although data on cardioprotective effects (as profile of troponin I)of perioperative maintenance of normothermia during CABGs are already known, little is known about the effects of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery. Being acute renal failure (ARF) and atrial fibrillation (AF) the two most frequent complications of this surgery, this study compare as primary end point the rate of postoperative ARF and AF in two group of patients, one actively warmed with Thermowrap and the control group receiving standard institutional care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated on pump CABGs\n* Age 18 - 85\n* Preoperative core temperature 36- 37.5 °C\n\nExclusion Criteria:\n\n* History of fever in the last week\n* Severe renal, hepatic,hematologic or pulmonary disease\n* Chronic Atrial fibrillation\n* History of acute MI in the last week\n* Previous neurologic abnormalities'}, 'identificationModule': {'nctId': 'NCT00791050', 'briefTitle': 'Examine the Effects of Maintaining Body Core Temperature During CABGs', 'organization': {'class': 'OTHER', 'fullName': 'Centro Cardiologico Monzino'}, 'officialTitle': 'To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap', 'orgStudyIdInfo': {'id': 'CCMAneste002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Thermo', 'interventionNames': ['Device: Allon Thermowrap. MTRE Advanced Technologies Ltd.']}, {'type': 'NO_INTERVENTION', 'label': '2 Control'}], 'interventions': [{'name': 'Allon Thermowrap. MTRE Advanced Technologies Ltd.', 'type': 'DEVICE', 'description': 'Thermowrap set at 37 °C before induction of anesthesia and maintained until initiation of CPB; during CPB set to "monitoring" and set again to 37 °C from rewarming during CPB to end of surgery.', 'armGroupLabels': ['1 Thermo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'contacts': [{'role': 'CONTACT', 'email': 'anestesisti@ccfm.it', 'phone': '+ 39 02 58002541'}, {'name': 'Luca Salvi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Luca Salvi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Cardiologico Monzino', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Luca Salvi, MD', 'oldOrganization': 'IRCCS Centro Cardiologico Monzino'}}}}