Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01996956
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2013-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2013-11-17', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stroke volume index', 'timeFrame': 'before and after volume loading (20 min)', 'description': 'Volume loading was performed for 20 minutes. Stroke volume measured before and after volume expansion using transesophageal echocardiography. And, stroke volume variation of NICOM monitor was recorded before fluid loading.'}], 'secondaryOutcomes': [{'measure': 'Cardiac index', 'timeFrame': 'before and after fluid loading (20 min)', 'description': 'Cardiac index measured by transesophageal echocardiography and NICOM monitor were compared before and after fluid loading for 20 min.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke volume variation,', 'cardiac output,', 'fluid responsiveness,', 'noninvasive cardiac output monitor'], 'conditions': ['Fluid Responsiveness']}, 'referencesModule': {'references': [{'pmid': '25926311', 'type': 'DERIVED', 'citation': 'Lee JH, No HJ, Song IK, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness using a non-invasive cardiac output monitor in children undergoing cardiac surgery. Br J Anaesth. 2015 Jul;115(1):38-44. doi: 10.1093/bja/aev109. Epub 2015 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* congenital cardiac surgery\n* \\< 6 years old\n* who were required the evaluation by transesophageal echocardiography\n\nExclusion Criteria:\n\n* right heart failure\n* supported by more than 2 inotropic agents\n* reduced kidney function\n* any valvar stenosis\n* moderate or severe tricuspid regurgitation\n* single ventricle'}, 'identificationModule': {'nctId': 'NCT01996956', 'briefTitle': 'Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'H-1303-114-478'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Volume loading', 'interventionNames': ['Other: volume expansion']}], 'interventions': [{'name': 'volume expansion', 'type': 'OTHER', 'description': 'fluid loading of 10 ml/kg colloid or blood product', 'armGroupLabels': ['Volume loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul national university hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}