Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-04 @ 10:28 AM
Study NCT ID:
NCT02244034
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Risk Factors of Postoperative Hypothermia in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 760}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2014-09-15', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of postoperative hypothermia in patients with cardiopulmonary bypass.', 'timeFrame': '24 hours', 'description': 'Upon arrival at the Cardiac Surgical Intensive Care Unit (CSICU), body temperature was measured using an infrared tympanic membrane thermometer. Postoperative hypothermia, which was defined as the body temperature \\< 36 degrees C upon arrival at the CSICU.'}], 'secondaryOutcomes': [{'measure': 'predictors of postoperative hypothermia in patients with cardiopulmonary bypass.', 'timeFrame': '24 hours', 'description': 'Predictors such as age, sex, body surface area, emergency surgery, time of operation, time of cardiopulmonary bypass time, fluid and blood component administer will be analyze.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Hypothermia in Patients With Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'Background: Postoperative hypothermia may result in relevant complications such as adverse cardiovascular events, wound infection, and coagulopathy with consecutive blood loss. Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158 patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface including wound surface are exposed. Many of these patients receive large amounts of infusions and transfusions, and undergo hemodilution during CPB, which may additionally contribute to development of hypothermia.\n\nObjective of the planned study is to find out incidence and duration of postoperative hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is the incidence of postoperative complications and its relation to postoperative core temperature.\n\nMethods: A retrospective chart review 780 patients who had been underwent cardiac surgery with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative hyperthermia (\\> 37.8 °C) and hypothermia (\\> 36 °C).\n\nThe following parameters will be recorded: temperature is measured at ICU after arrived and after 6 hours which is primary outcome, biometric data include age, sex, body weight, height, ASA physical status, surgical procedure includes emergency cases, anesthetic and surgical (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest temperature during bypass, method of temperature protection, and the outcome of operation .\n\nAll data will be described in number and percent and Pearson chi-square method will be used for analyze correlation between hypothermia and risk factor . P-value \\<0.05 will be defined to significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who had been underwent cardiac surgery with CPB during 2012-2013', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients ≥ 18 years old\n\nExclusion Criteria:\n\n* patients with preoperative hyperthermia (\\> 37.8 °C) and hypothermia (\\< 36 °C).'}, 'identificationModule': {'nctId': 'NCT02244034', 'briefTitle': 'Incidence and Risk Factors of Postoperative Hypothermia in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Incidence and Risk Factors of Postoperative Hypothermia in Patients With Cardiopulmonary Bypass.', 'orgStudyIdInfo': {'id': 'SI002'}}, 'armsInterventionsModule': {'armGroups': [{'label': '760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB', 'interventionNames': ['Procedure: hypothermia']}], 'interventions': [{'name': 'hypothermia', 'type': 'PROCEDURE', 'armGroupLabels': ['760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of medicine Siriraj hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'instructor', 'investigatorFullName': 'Chaowanan Khamtuikrua', 'investigatorAffiliation': 'Mahidol University'}}}}