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

August 6, 2013 updated by: University of Aarhus

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Århus, Denmark, 8200
        • Department of Anaesthesia & Intensive Care, Århus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dobutamine
Drug: Dobutamine
90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 0 to 90 minutes after drug initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 0 to 90 minutes after drug initiation.
Echocardiography
Time Frame: From 0 minutes to 90 minutes after drug initiation
Echocardiographic measures of systolic and diastolic heart function.
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
Changes in mixed venous saturation (in per cent) from baseline until the end of dobutrex or placebo infusion.
From 0 minutes to 90 minutes after drug initiation
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
From 0 minutes to 90 minutes after drug initiation
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.
From 0 minutes to 90 minutes after drug initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Erik Sloth, Professor, Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (ESTIMATE)

June 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1818

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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