Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-21 @ 5:42 AM
Study NCT ID:
NCT02617602
Status:
UNKNOWN
Last Update Posted:
2015-12-18
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074388', 'term': 'Early Goal-Directed Therapy'}], 'ancestors': [{'id': 'D003422', 'term': 'Critical Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major complications', 'timeFrame': 'Through study completion, an average of 30 days', 'description': 'Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of "injury" or higher), sepsis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Congenital heart defect', 'Cardiopulmonary bypass', 'Goal directed therapy', 'Acute heart failure'], 'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular performance and allows for timely interventions based on predetermined algorithms. The aim of this prospective randomised study is to evaluate the effect of GDT on major complications in children undergoing radical correction of congenital heart defects, complicated by acute heart failure. Goal directed therapy will be implemented with the aid of transpulmonary thermodilution and based on predetermined algorithms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed written consent signed by legal representative (parent or guardian)\n* radical correction of congenital heart defect(s)\n* use of cardiopulmonary bypass\n* vasoactive-inotropic Score of 10 or greater during first 24 hours after surgery.\n\nExclusion Criteria:\n\n* confirmed intranatal infection;\n* gestational age \\< 37 weeks;\n* inotropic support prior to surgery;\n* acute renal or hepatic failure prior to surgery;\n* participation in conflicting randomised controlled studies.'}, 'identificationModule': {'nctId': 'NCT02617602', 'briefTitle': 'Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children: a Prospective Randomised Trial', 'orgStudyIdInfo': {'id': 'GDT1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Goal directed therapy', 'description': 'Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals', 'interventionNames': ['Procedure: Goal directed therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Conventional therapy', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Goal directed therapy', 'type': 'PROCEDURE', 'description': 'Based on transpulmonary thermodilution data, the following interventions will be implemented:\n\nGlobal end diastolic volume (GEDV) ≤ 430 ml/m2 and extravascular water index (EVWI) ≤ 10 ml/kg: fluid load; GEDV ≥ 550 ml/m2 and EVWI ≥ 10 ml/kg: furosemide;\n\ncardiac index (CI) ≤ 2 l/min/m2 - inotropic support:\n\n* decreased heart rate (HR): dobutamine, dopamine;\n* normal or increased HR: epinephrine, norepinephrine; CI ≥ 2 l/min/m2 and normovolemia: phenylephrine.', 'armGroupLabels': ['Goal directed therapy']}, {'name': 'Control', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Dmitry Ponomarev, PhD', 'role': 'CONTACT', 'email': 'd_ponomarev@meshalkin.ru', 'phone': '+79232339205'}], 'facility': 'Novosibirsk Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Vladimir Lomivorotov, PhD', 'role': 'CONTACT', 'email': 'vv_lomivorotov@meshalkin.ru', 'phone': '+79139164103'}, {'name': 'Dmitry Ponomarev, PhD', 'role': 'CONTACT', 'email': 'd_ponomarev@meshalkin.ru', 'phone': '+79232339205'}], 'overallOfficials': [{'name': 'Vladimir Lomivorotov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novosibirsk Research Institute of Cirulation Pathology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}