Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT02826135
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2016-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Fluid Responsiveness in Children With Single Ventricle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in stroke volume index after volume expansion', 'timeFrame': 'before and after fluid administration (20 min)'}], 'secondaryOutcomes': [{'measure': 'Changes in pleth variability index after volume expansion', 'timeFrame': 'before and after fluid administration (20 min)'}, {'measure': '3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion', 'timeFrame': 'before and after fluid administration (20 min)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypovolemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).', 'detailedDescription': 'The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).\n\nWhen there are clinical signs of hypovolemia, such as hypotension, decreased urine output or decreased central venous pressure, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.\n\nTo evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration.\n\nFinally, patients will be divided into fluid responder group and non-responder group. If cardiac output measured using echocardiography increases over 15% after fluid administration, the patient is fluid responder. Using ROC curve, diagnostic power of abdominal compression-induced blood pressure change for fluid responsiveness will be evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery\n* Patients with bidirectional cavopulmonary shunt or fontan tract\n\nExclusion Criteria:\n\n* renal, hepatic and pulmonary disease\n* preoperative infection: increased CPR, WBC over 10,000, and with fever\n* genetic and hematologic disease\n* ventricular dysfunction\n* increased intracranial pressure'}, 'identificationModule': {'nctId': 'NCT02826135', 'briefTitle': 'Prediction of Fluid Responsiveness in Children With Single Ventricle', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-Induced Change of Blood Pressure in Children With Bidirectional Cavopulmonary Shunt or Fontan Pathway', 'orgStudyIdInfo': {'id': 'H1603-156-752'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric patients with hypovolemic state', 'description': 'Right upper abdominal compression is performed in patients with hypovolemic signs including hypotension, decreased urine output or decreased central venous pressure. Changes of blood pressure during abdominal compression is continuously recorded.', 'interventionNames': ['Procedure: abdominal compression']}], 'interventions': [{'name': 'abdominal compression', 'type': 'PROCEDURE', 'description': 'When there are clinical signs of hypovolemia, such as hypotension in pediatric patients with single ventricle, decreased urine output or decreased central venous pressure, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.', 'armGroupLabels': ['Pediatric patients with hypovolemic state']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}