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

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ClinicalTrials.gov Identifier: NCT01375335
Recruitment Status : Suspended (Insufficient patient eligible for recruitment)
First Posted : June 17, 2011
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Drug: Dobutamine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : June 2011
Actual Primary Completion Date : August 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Echocardiography [ Time Frame: From 0 minutes to 90 minutes after drug initiation ]
    Echocardiographic measures of systolic and diastolic heart function.

  3. 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.

  4. 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

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
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
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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
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Denmark
Department of Anaesthesia & Intensive Care, Århus University Hospital
Århus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Chair: Erik Sloth, Professor Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01375335    
Other Study ID Numbers: 1818
First Posted: June 17, 2011    Key Record Dates
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:
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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