Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT02306057
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2014-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluid Balance in Children Undergoing Fontan Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018636', 'term': 'Hypoplastic Left Heart Syndrome'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Interstitial fluid Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-08', 'studyFirstSubmitDate': '2014-10-31', 'studyFirstSubmitQcDate': '2014-11-28', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interstitial colloid osmotic pressure', 'timeFrame': 'Before and after surgery or catheterization', 'description': 'Change in interstitial colloid osmotic pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Defects, Congenital', 'Hypoplastic Left Heart Syndrome']}, 'referencesModule': {'references': [{'pmid': '30371784', 'type': 'DERIVED', 'citation': 'Indrebo M, Berg A, Holmstrom H, Seem E, Guthe HJT, Wiig H, Norgard G. Fluid accumulation in the staged Fontan procedure: the impact of colloid osmotic pressures. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):510-517. doi: 10.1093/icvts/ivy298.'}]}, 'descriptionModule': {'briefSummary': 'This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein.\n\nThe study hypothesis are\n\n1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.\n2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.\n3. Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with congenital heart defect scheduled for Fontan surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Diagnosis of Congenital heart defect in need of Fontan procedure -\n\nExclusion Criteria: No parental consent\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02306057', 'briefTitle': 'Fluid Balance in Children Undergoing Fontan Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia', 'orgStudyIdInfo': {'id': '063.09b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre BCPC', 'description': 'Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure', 'interventionNames': ['Procedure: Pre BCPC']}, {'label': 'BCPC surgery', 'description': 'Children undergoing surgical BCPC procedure', 'interventionNames': ['Procedure: BCPC surgery']}, {'label': 'Pre TCPC', 'description': 'Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure', 'interventionNames': ['Procedure: Pre TCPC']}, {'label': 'TCPC surgery', 'description': 'Children undergoing surgical TCPC procedure', 'interventionNames': ['Procedure: TCPC']}], 'interventions': [{'name': 'Pre BCPC', 'type': 'PROCEDURE', 'description': 'Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection', 'armGroupLabels': ['Pre BCPC']}, {'name': 'Pre TCPC', 'type': 'PROCEDURE', 'description': 'Routine catheterization before surgical procedure Total CavoPulmonary Connection', 'armGroupLabels': ['Pre TCPC']}, {'name': 'BCPC surgery', 'type': 'PROCEDURE', 'description': 'Surgical procedure Bidirectional CavoPulmonary Connection', 'armGroupLabels': ['BCPC surgery']}, {'name': 'TCPC', 'type': 'PROCEDURE', 'description': 'Surgical procedure Total CavoPulmonary Connection', 'armGroupLabels': ['TCPC surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Marianne Indrebø, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bergen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Research fellow', 'investigatorFullName': 'Marianne Indrebo', 'investigatorAffiliation': 'Oslo University Hospital'}}}}