Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-09 @ 12:21 PM
Study NCT ID:
NCT04536194
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2020-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dopamine Versus Norepinephrine Under General Anesthesia
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': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D004298', 'term': 'Dopamine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of cardiac index', 'timeFrame': '20 minutes', 'description': 'the differences of cardiac index between after and before the intervention (l/min/m2)'}], 'secondaryOutcomes': [{'measure': 'changes of stroke volume index', 'timeFrame': '20 minutes', 'description': 'the differences of stroke volume index between after and before the intervention (ml/m2)'}, {'measure': 'changes of systemic vascular resistance index', 'timeFrame': '20 minutes', 'description': 'the differences of systemic vascular resistance index between after and before the intervention(dyne ∙ sec ∙ m2/cm5)'}, {'measure': 'changes of the maximal slope of systolic upstroke', 'timeFrame': '20 minutes', 'description': 'the differences of the maximal slope of systolic upstroke between after and before the intervention(mmHg/ms)'}, {'measure': 'changes of heart rate', 'timeFrame': '20 minutes', 'description': 'the differences of heart rate between after and before the intervention (bpm)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['norepinephrine', 'dopamine'], 'conditions': ['Anesthesia', 'Infant', 'Congenital Heart Disease', 'Hemodynamic Instability']}, 'referencesModule': {'references': [{'pmid': '29891225', 'type': 'BACKGROUND', 'citation': 'Yuan SM. Acute kidney injury after pediatric cardiac surgery. Pediatr Neonatol. 2019 Feb;60(1):3-11. doi: 10.1016/j.pedneo.2018.03.007. Epub 2018 Mar 30.'}, {'pmid': '30613600', 'type': 'BACKGROUND', 'citation': 'Foulon P, De Backer D. The hemodynamic effects of norepinephrine: far more than an increase in blood pressure! Ann Transl Med. 2018 Nov;6(Suppl 1):S25. doi: 10.21037/atm.2018.09.27. No abstract available.'}, {'pmid': '29538053', 'type': 'BACKGROUND', 'citation': 'Cavigelli-Brunner A, Hug MI, Dave H, Baenziger O, Buerki C, Bettex D, Cannizzaro V, Balmer C. Prevention of Low Cardiac Output Syndrome After Pediatric Cardiac Surgery: A Double-Blind Randomized Clinical Pilot Study Comparing Dobutamine and Milrinone. Pediatr Crit Care Med. 2018 Jul;19(7):619-625. doi: 10.1097/PCC.0000000000001533.'}, {'pmid': '26415680', 'type': 'BACKGROUND', 'citation': 'Saxena R, Durward A, Steeley S, Murdoch IA, Tibby SM. Predicting fluid responsiveness in 100 critically ill children: the effect of baseline contractility. Intensive Care Med. 2015 Dec;41(12):2161-9. doi: 10.1007/s00134-015-4075-8. Epub 2015 Sep 28.'}, {'pmid': '29452808', 'type': 'RESULT', 'citation': 'Hamzaoui O, Jozwiak M, Geffriaud T, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Richard C, Teboul JL. Norepinephrine exerts an inotropic effect during the early phase of human septic shock. Br J Anaesth. 2018 Mar;120(3):517-524. doi: 10.1016/j.bja.2017.11.065. Epub 2017 Nov 21.'}, {'pmid': '27481679', 'type': 'RESULT', 'citation': 'Favia I, Rizza A, Garisto C, Haiberger R, Di Chiara L, Romagnoli S, Ricci Z. Cardiac index assessment by the pressure recording analytical method in infants after paediatric cardiac surgery: a pilot retrospective study. Interact Cardiovasc Thorac Surg. 2016 Dec;23(6):919-923. doi: 10.1093/icvts/ivw251. Epub 2016 Aug 1.'}, {'pmid': '25179459', 'type': 'RESULT', 'citation': 'Urbano J, Lopez J, Gonzalez R, Solana MJ, Fernandez SN, Bellon JM, Lopez-Herce J. Measurement of cardiac output in children by pressure-recording analytical method. Pediatr Cardiol. 2015 Feb;36(2):358-64. doi: 10.1007/s00246-014-1014-3. Epub 2014 Sep 2.'}, {'pmid': '24491036', 'type': 'RESULT', 'citation': 'Garisto C, Favia I, Ricci Z, Romagnoli S, Haiberger R, Polito A, Cogo P. Pressure recording analytical method and bioreactance for stroke volume index monitoring during pediatric cardiac surgery. Paediatr Anaesth. 2015 Feb;25(2):143-9. doi: 10.1111/pan.12360. Epub 2014 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'Participants under general anesthesia will be randomly treated with an adjusted dose dopamine or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is recorded by PRAM and the change of cardiac index is compared between groups.', 'detailedDescription': 'After intubation under general anesthesia, radial arterial is cannulated and pressure transducer is connected to MostCare(core technique PRAM). CI, SVRI, SVI, SVV, dp/dt and HR are recorded before and after a infusion of dopamine or norepinephrine to elevate 10% of mean arterial pressure. Changes of these hemodynamic data are compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undertake cardiac surgery for congenital heart disease\n\nExclusion Criteria:\n\n* Aortic valve or aortic disease\n* severe arrhythmia\n* use of cardiovascular active drugs before anesthesia\n* need to use a combination of different cardiovascular support drugs after anesthesia'}, 'identificationModule': {'nctId': 'NCT04536194', 'briefTitle': 'Dopamine Versus Norepinephrine Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Hemodynamic Effects of Dopamine Versus Norepinephrine Under General Anesthesia in Infant With Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'mzk-0003-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'norepinephrine', 'description': 'infusion of norepinephrine with a adjusted dose to elevate 10% of mean arterial pressure', 'interventionNames': ['Drug: norepinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dopamine', 'description': 'infusion of dopamine with a adjusted dose to elevate 10% of mean arterial pressure', 'interventionNames': ['Drug: dopamine']}], 'interventions': [{'name': 'norepinephrine', 'type': 'DRUG', 'description': 'to treat hypotension under general anesthesia with norepinephrine', 'armGroupLabels': ['norepinephrine']}, {'name': 'dopamine', 'type': 'DRUG', 'description': 'to treat hypotension under general anesthesia with dopamine', 'armGroupLabels': ['Dopamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'accessCriteria': 'share to researchers by email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice director of department of anesthesiology', 'investigatorFullName': 'Zhijian Zhou', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}