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

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.
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):

June 14, 2011
June 17, 2011
August 7, 2013
June 2011
August 2013   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01375335 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
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
Experimental: Dobutamine
Intervention: Drug: Dobutamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
Not Provided
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01375335
1818
Yes
Not Provided
Not Provided
University of Aarhus
University of Aarhus
Not Provided
Study Chair: Erik Sloth, Professor Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
University of Aarhus
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP