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

The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis

Status

Suspended

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01375335

Enrollment

Registered

2011-06-17

Start date

2011-06-30

Completion date

Unknown

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Postoperative, Dobutamine, Inotropes, Stunning, Heart failure

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.

Interventions

DRUGDobutamine

90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026