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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Dobutamine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized
- 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.
- 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.
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
|Department of Anaesthesia & Intensive Care, Århus University Hospital|
|Århus, Denmark, 8200|
|Study Chair:||Erik Sloth, Professor||Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital|