The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
This study has suspended participant recruitment.
(Insufficient patient eligible for recruitment)
Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01375335
First received: June 14, 2011
Last updated: August 6, 2013
Last verified: August 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: Dobutamine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial hypertrophic cardiomyopathy
supravalvular aortic stenosis
MedlinePlus related topics:
Heart Failure
U.S. FDA Resources
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- Cardiac output [ Time Frame: From 0 to 90 minutes after drug initiation ] [ Designated as safety issue: No ]Change in cardiac output (l/min) from initiation of study drug or placebo until 90 minutes of infusion.
Secondary Outcome Measures:
- Mean pulmonary artery pressure [ Time Frame: From 0 to 90 minutes after drug initiation. ] [ Designated as safety issue: No ]Changes in pulmonary artery pressure (mmHg) from start of study drug or placebo infusion until 90 minutes after the start.
- Echocardiography [ Time Frame: From 0 minutes to 90 minutes after drug initiation ] [ Designated as safety issue: No ]Echocardiographic measures of systolic and diastolic heart function.
- Changes in mixed venous saturation [ Time Frame: From 0 minutes to 90 minutes after drug initiation ] [ Designated as safety issue: No ]Changes in mixed venous saturation (in per cent) from baseline until the end of dobutrex or placebo infusion.
- norepinephrine requirement [ Time Frame: From 0 minutes to 90 minutes after drug initiation ] [ Designated as safety issue: Yes ]The amount of norepinephrinem(mg) required to maintain adequate systemic blood pressure during the infusion period of dobutrex and placebo
- Central venous pressure [ Time Frame: From 0 minutes to 90 minutes after drug initiation ] [ Designated as safety issue: No ]Changes in CVP from baseline until 90 minutes of study drug or placebo infusion.
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2011 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dobutamine |
Drug: Dobutamine
90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized
|
Eligibility| Ages Eligible for Study: | 19 Years to 90 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18-90 years
- Left ventricular posterior wall =/>12mm
- Ejection fraction > 45%
- Sinus rhythm
- Eligible for aortic valve replacement
Exclusion Criteria:
- Need for concomitant cardiac bypass operation.
- Moderate or severe insufficiency of the mitral valve
- Active endocarditis
- Insufficient ultrasound window
- Using B-blockers
- Liver insufficiency
- Patients treated with COMT-inhibitors
- Allergy towards dobutamine
- Pregnancy
- Women of fertile age who do not use relevant anti-conception
- Lacking participant consent
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375335
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375335
Locations
| Denmark | |
| Department of Anaesthesia & Intensive Care, Århus University Hospital | |
| Århus, Denmark, 8200 | |
Sponsors and Collaborators
University of Aarhus
Investigators
| Study Chair: | Erik Sloth, Professor | Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital |
More Information
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01375335 History of Changes |
| Other Study ID Numbers: | 1818 |
| Study First Received: | June 14, 2011 |
| Last Updated: | August 6, 2013 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by University of Aarhus:
|
Postoperative Dobutamine Inotropes Stunning Heart failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Dobutamine Cardiotonic Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on September 23, 2016