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

Phase 4

Suspended

• Conditions: Heart Failure
• Interventions: Drug: Dobutamine

• Registration Number: NCT01375335
• Lead Sponsor: University of Aarhus

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 available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-17
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dobutamine	Dobutamine	-

Primary Outcome Measures

Name	Time	Method
Cardiac output	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.

Secondary Outcome Measures

Name	Time	Method
Mean pulmonary artery pressure	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	From 0 minutes to 90 minutes after drug initiation	Echocardiographic measures of systolic and diastolic heart function.
Changes in mixed venous saturation	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	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	From 0 minutes to 90 minutes after drug initiation	Changes in CVP from baseline until 90 minutes of study drug or placebo infusion.

Trial Locations

Locations (1)

Department of Anaesthesia & Intensive Care, Århus University Hospital; 🇩🇰 Århus, Denmark