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