Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-29 @ 7:20 AM
Study NCT ID:
NCT02945358
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of OHIR Score to Predict a Prolonged Intensive Care Unit Stay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensive care stay', 'timeFrame': 'through study completion, an average of 1 week', 'description': 'number of hours admitted in ICU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ICU Stay']}, 'referencesModule': {'references': [{'pmid': '20185517', 'type': 'RESULT', 'citation': 'Williams TA, Ho KM, Dobb GJ, Finn JC, Knuiman M, Webb SA; Royal Perth Hospital ICU Data Linkage Group. Effect of length of stay in intensive care unit on hospital and long-term mortality of critically ill adult patients. Br J Anaesth. 2010 Apr;104(4):459-64. doi: 10.1093/bja/aeq025. Epub 2010 Feb 25.'}, {'pmid': '16488688', 'type': 'RESULT', 'citation': 'Hein OV, Birnbaum J, Wernecke K, England M, Konertz W, Spies C. Prolonged intensive care unit stay in cardiac surgery: risk factors and long-term-survival. Ann Thorac Surg. 2006 Mar;81(3):880-5. doi: 10.1016/j.athoracsur.2005.09.077.'}, {'pmid': '15875128', 'type': 'RESULT', 'citation': 'Nakasuji M, Matsushita M, Asada A. Risk factors for prolonged ICU stay in patients following coronary artery bypass grafting with a long duration of cardiopulmonary bypass. J Anesth. 2005;19(2):118-23. doi: 10.1007/s00540-005-0301-9.'}, {'pmid': '16926372', 'type': 'RESULT', 'citation': 'Gruenberg DA, Shelton W, Rose SL, Rutter AE, Socaris S, McGee G. Factors influencing length of stay in the intensive care unit. Am J Crit Care. 2006 Sep;15(5):502-9.'}, {'pmid': '27279475', 'type': 'RESULT', 'citation': 'Almashrafi A, Alsabti H, Mukaddirov M, Balan B, Aylin P. Factors associated with prolonged length of stay following cardiac surgery in a major referral hospital in Oman: a retrospective observational study. BMJ Open. 2016 Jun 8;6(6):e010764. doi: 10.1136/bmjopen-2015-010764.'}, {'pmid': '27473872', 'type': 'RESULT', 'citation': 'Almashrafi A, Elmontsri M, Aylin P. Systematic review of factors influencing length of stay in ICU after adult cardiac surgery. BMC Health Serv Res. 2016 Jul 29;16:318. doi: 10.1186/s12913-016-1591-3.'}, {'pmid': '24818129', 'type': 'RESULT', 'citation': 'Tribuddharat S, Sathitkarnmanee T, Ngamsangsirisup K, Charuluxananan S, Hurst CP, Silarat S, Lertmemongkolchai G. Development of an open-heart intraoperative risk scoring model for predicting a prolonged intensive care unit stay. Biomed Res Int. 2014;2014:158051. doi: 10.1155/2014/158051. Epub 2014 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'A prolonged stay in intensive care unit (ICU) after cardiac surgery with cardiopulmonary bypass increases not only cost of patient care but also morbidity and mortality of patients. The ability to predict which patient has the tendency to have a prolonged ICU stay would help in patient and resource management of the hospital. There are many predictive models aiming at identifying patient at risk of prolonged ICU stay after cardiac surgery with cardiopulmonary bypass but almost all involve the preoperative assessment for proper resource management with one model, Open-Heart Intraoperative Risk (OHIR) Scoring concerning intraoperative manipulatable risk factors to improve anesthetic care and patient outcome. The OHIR model comprises 6 risk factors, 5 of which can be managed intraoperatively, with total score of 7 and a score of ≥ 3 indicating a likely prolonged ICU stay. The objective of this study was to re-validate the performance of OHIR score in the recent context.', 'detailedDescription': "This will be a retrospective, observational, analytical study. The study protocol was approved by the Human Research Ethics Committee, Khon Kaen University (HE581287).\n\nThe investigators will review all eligible medical records at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Khon Kaen University during January 2013 and December 2014. The extracted data consist of patient's clinical data and all risk factors in the OHIR score. The investigators will apply the OHIR scoring to the data to assess its performance. The investigators will use the same criteria for a prolonged ICU stay as in the previous study, i.e. a stay longer that the median."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing open-heart surgery both CABG and valve surgery with cardiopulmonary pump', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18-75 undergoing cardiac surgery, both CABG and valvular surgery, with the use of cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* patients having emergency surgery; receiving special devices such as intra-aortic balloon pump or extracorporeal membrane oxygenation.'}, 'identificationModule': {'nctId': 'NCT02945358', 'briefTitle': 'Assessment of OHIR Score to Predict a Prolonged Intensive Care Unit Stay', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Assessment of OHIR Score to Predict a Prolonged Intensive Care Unit Stay for Adult Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'HE581287'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prolonged ICU stay', 'description': 'Group 1: adult cardiac surgery with cardiopulmonary pump with prolonged ICU stay Group 2: adult cardiac surgery with cardiopulmonary pump with non-prolonged ICU stay', 'interventionNames': ['Procedure: adult cardiac surgery with cardiopulmonary pump']}], 'interventions': [{'name': 'adult cardiac surgery with cardiopulmonary pump', 'type': 'PROCEDURE', 'description': 'Open-heart surgery both coronary artery bypass graft (CABG) and valve surgery', 'armGroupLabels': ['Prolonged ICU stay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Queen Sirikit Heart Center', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '40002', 'city': 'Khon Kaen', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital, Faculty of Medicine, Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Sirirat Tribuddharat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thepakorn Sathitkarnmanee', 'investigatorAffiliation': 'Khon Kaen University'}}}}