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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01375335
• Date of registration: 14/06/2011
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
• Scientific title: The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis
• Date of first enrolment: June 2011
• Target sample size: 10
• Recruitment status: Suspended
• URL: http://clinicaltrials.gov/show/NCT01375335
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Erik Sloth, Professor
• Affiliation: Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Drug: Dobutamine

Primary Outcome(s)

Cardiac output [Time Frame: From 0 to 90 minutes after drug initiation]

Secondary Outcome(s)

Echocardiography [Time Frame: From 0 minutes to 90 minutes after drug initiation]

Changes in mixed venous saturation [Time Frame: From 0 minutes to 90 minutes after drug initiation]

Central venous pressure [Time Frame: From 0 minutes to 90 minutes after drug initiation]

norepinephrine requirement [Time Frame: From 0 minutes to 90 minutes after drug initiation]

Mean pulmonary artery pressure [Time Frame: From 0 to 90 minutes after drug initiation.]

Secondary ID(s)

1818

Source(s) of Monetary Support

Please refer to primary and secondary sponsors