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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):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE June 14, 2011
First Posted Date  ICMJE June 17, 2011
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2011)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
Official Title  ICMJE The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Dobutamine
Intervention: Drug: Dobutamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 15, 2011)		 10
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01375335
Other Study ID Numbers  ICMJE 1818
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Aarhus
Original Responsible Party Professor Erik Sloth, Department of Anaesthesia & Intensive Care, Århus University Hospital
Current Study Sponsor  ICMJE University of Aarhus
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Erik Sloth, Professor Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
PRS Account University of Aarhus
Verification Date August 2013

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