The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement

This study has suspended participant recruitment.

(Insufficient patient eligible for recruitment)

Sponsor:

ClinicalTrials.gov Identifier:

NCT01375335

First Posted: June 17, 2011

Last Update Posted: August 7, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

University of Aarhus

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 Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, 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

Drug Information available for: Dobutamine Dobutamine hydrochloride

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

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 ]
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. ]
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 ]
Echocardiographic measures of systolic and diastolic heart function.
Changes in mixed venous saturation [ Time Frame: From 0 minutes to 90 minutes after drug initiation ]
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 ]
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 ]
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

Information from the National Library of Medicine

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Ages Eligible for Study:	19 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	June 14, 2011
First Posted:	June 17, 2011
Last Update Posted:	August 7, 2013
Last Verified:	August 2013

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

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