Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-27 @ 10:23 PM
Study NCT ID:
NCT01338961
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2011-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normothermia Versus Hypothermia for Valvular Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2011-04-18', 'studyFirstSubmitQcDate': '2011-04-19', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Troponin I release', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Need for Inotropic Support', 'timeFrame': 'First 48 postoperative hours'}, {'measure': 'Rate of Perioperative Myocardial Infarction', 'timeFrame': 'First 48 postoperative hours'}, {'measure': 'Rate of Type I and Type II neurological injury', 'timeFrame': '7 postoperative days'}, {'measure': 'Rate of Dialysis-dependent acute renal failure', 'timeFrame': '7 postoperative days'}, {'measure': 'Rate of infectious complications', 'timeFrame': '30 postoperative days'}, {'measure': 'Total units of Red Blood Cells transfused', 'timeFrame': '7 postoperative days'}, {'measure': 'Intensive Care Unit length of stay', 'timeFrame': '30 postoperative days'}, {'measure': 'Hospital length of stay', 'timeFrame': '30 postoperative days'}, {'measure': 'Rate of In-hospital mortality', 'timeFrame': '30 postoperative days'}, {'measure': 'NT-proBNP release', 'timeFrame': 'First 24 postoperative hours'}, {'measure': 'Bleeding from chest tubes', 'timeFrame': 'First 24 postoperative hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary Bypass', 'Hypothermia', 'Normothermia', 'Troponin I', 'Bleeding'], 'conditions': ['Valvular Heart Disease']}, 'referencesModule': {'references': [{'pmid': '23962460', 'type': 'RESULT', 'citation': 'Lomivorotov VV, Shmirev VA, Efremov SM, Ponomarev DN, Moroz GB, Shahin DG, Kornilov IA, Shilova AN, Lomivorotov VN, Karaskov AM. Hypothermic versus normothermic cardiopulmonary bypass in patients with valvular heart disease. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):295-300. doi: 10.1053/j.jvca.2013.03.009. Epub 2013 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date, most studies have been conducted in coronary artery bypass graft (CABG) patients with conflicting results. Current evidence does not support one temperature management strategy for all patients. The purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic CPB in valvular surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated heart valve surgery\n* Heart valve surgery plus CABG\n* Age 20-80\n\nExclusion Criteria:\n\n* urgent operation\n* Left ventricle ejection fraction \\< 35%\n* Decompensated congestive heart failure\n* Chronic renal failure (glomerular filtration rate \\< 60 ml/min)\n* Severe hepatic and pulmonary disease\n* Bleeding diathesis or history of coagulopathy\n* Planed deep hypothermic circulatory arrest\n* History of acute myocardial infarction in the last 3 month\n* Preoperative core temperature \\>37oC'}, 'identificationModule': {'nctId': 'NCT01338961', 'briefTitle': 'Normothermia Versus Hypothermia for Valvular Surgery Patients', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.', 'orgStudyIdInfo': {'id': 'HYPO-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Normothermic CPB', 'description': 'Standard management. Patients will be kept at normothermia throughout the procedure (\\>36oC).'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypothermic CPB', 'description': 'Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC.', 'interventionNames': ['Procedure: Hypothermic CPB']}], 'interventions': [{'name': 'Hypothermic CPB', 'type': 'PROCEDURE', 'description': 'Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC', 'armGroupLabels': ['Hypothermic CPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'State Research Institute of Circulation Patholody', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'overallOfficials': [{'name': 'Vladimir V Lomivorotov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute of Pathology of Circulation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesist', 'investigatorFullName': 'Efremov Sergey', 'investigatorAffiliation': 'Meshalkin Research Institute of Pathology of Circulation'}}}}