Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 8:18 PM
Study NCT ID:
NCT01364103
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery
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': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-05-31', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stoke volume index', 'timeFrame': 'before and after volume loading (20 minutes)', 'description': 'Volume loading will be performed for 20 minutes. Stroke volume will be meausred before and after volume expansion'}]}, 'conditionsModule': {'keywords': ['pulse pressure variation', 'systolic pressure variation', 'central venous pressure', 'aortic blood flow velocity variation', 'pleth variability index'], 'conditions': ['Fluid Responsiveness']}, 'referencesModule': {'references': [{'pmid': '23250892', 'type': 'DERIVED', 'citation': 'Byon HJ, Lim CW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery. Br J Anaesth. 2013 Apr;110(4):586-91. doi: 10.1093/bja/aes467. Epub 2012 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate static and dynamic parameters, echocardiographic parameters, and pleth variability index for predicting fluid responsiveness in children. Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart rate, central venous pressure, systolic pressure variation, pulse pressure variation, delta down, aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth variability index will be measure before and after volume expansion. Patients will be classified as responders to volume loading if stoke volume index increase by at least 15%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neurosurgery under general anesthesia\n* \\< 8 years old\n\nExclusion Criteria:\n\n* cardiac disease\n* pulmonary, renal and hepatic disease\n* infectious disease\n* hematologic and muscular disease'}, 'identificationModule': {'nctId': 'NCT01364103', 'briefTitle': 'Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'H-1012-118-345'}}, 'armsInterventionsModule': {'interventions': [{'name': 'volume expansion', 'type': 'OTHER', 'description': 'fluid loading of 10 mL/kg colloid (voluven)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul national university hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'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': 'assistant professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}