Ignite Creation Date:
2025-12-24 @ 10:24 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT01375335
Status:
SUSPENDED
Last Update Posted:
2013-08-07
First Post:
2011-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004280', 'term': 'Dobutamine'}], 'ancestors': [{'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'whyStopped': 'Insufficient patient eligible for recruitment', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2011-06-14', 'studyFirstSubmitQcDate': '2011-06-15', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output', 'timeFrame': 'From 0 to 90 minutes after drug initiation', 'description': 'Change in cardiac output (l/min) from initiation of study drug or placebo until 90 minutes of infusion.'}], 'secondaryOutcomes': [{'measure': 'Mean pulmonary artery pressure', 'timeFrame': 'From 0 to 90 minutes after drug initiation.', 'description': 'Changes in pulmonary artery pressure (mmHg) from start of study drug or placebo infusion until 90 minutes after the start.'}, {'measure': 'Echocardiography', 'timeFrame': 'From 0 minutes to 90 minutes after drug initiation', 'description': 'Echocardiographic measures of systolic and diastolic heart function.'}, {'measure': 'Changes in mixed venous saturation', 'timeFrame': 'From 0 minutes to 90 minutes after drug initiation', 'description': 'Changes in mixed venous saturation (in per cent) from baseline until the end of dobutrex or placebo infusion.'}, {'measure': 'norepinephrine requirement', 'timeFrame': 'From 0 minutes to 90 minutes after drug initiation', 'description': 'The amount of norepinephrinem(mg) required to maintain adequate systemic blood pressure during the infusion period of dobutrex and placebo'}, {'measure': 'Central venous pressure', 'timeFrame': 'From 0 minutes to 90 minutes after drug initiation', 'description': 'Changes in CVP from baseline until 90 minutes of study drug or placebo infusion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postoperative', 'Dobutamine', 'Inotropes', 'Stunning', 'Heart failure'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. This study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-90 years\n* Left ventricular posterior wall =/\\>12mm\n* Ejection fraction \\> 45%\n* Sinus rhythm\n* Eligible for aortic valve replacement\n\nExclusion Criteria:\n\n* Need for concomitant cardiac bypass operation.\n* Moderate or severe insufficiency of the mitral valve\n* Active endocarditis\n* Insufficient ultrasound window\n* Using B-blockers\n* Liver insufficiency\n* Patients treated with COMT-inhibitors\n* Allergy towards dobutamine\n* Pregnancy\n* Women of fertile age who do not use relevant anti-conception\n* Lacking participant consent'}, 'identificationModule': {'nctId': 'NCT01375335', 'briefTitle': 'The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis', 'orgStudyIdInfo': {'id': '1818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dobutamine', 'interventionNames': ['Drug: Dobutamine']}], 'interventions': [{'name': 'Dobutamine', 'type': 'DRUG', 'description': '90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized', 'armGroupLabels': ['Dobutamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Anaesthesia & Intensive Care, Århus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Erik Sloth, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}