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SuspendedNCT01375335Updated Aug 7, 2013

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

A Phase 4 interventional study of Dobutamine in Heart Failure, sponsored by University of Aarhus. Suspended at 1 site in Denmark. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment

Why this study was suspended
Insufficient patient eligible for recruitment
Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
19 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Heart Failure

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Keywords

  • Postoperative
  • Dobutamine
  • Inotropes
  • Stunning
  • Heart failure
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 10 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-90 years
  • Left ventricular posterior wall =/>12mm
  • Ejection fraction > 45%
  • Sinus rhythm
  • Eligible for aortic valve replacement

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Dobutamine

    Drug: Dobutamine

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

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What researchers measure

Primary outcomes

  1. Cardiac output

    Change in cardiac output (l/min) from initiation of study drug or placebo until 90 minutes of infusion.

    Time frame: From 0 to 90 minutes after drug initiation

Secondary outcomes

  1. Mean pulmonary artery pressure

    Changes in pulmonary artery pressure (mmHg) from start of study drug or placebo infusion until 90 minutes after the start.

    Time frame: From 0 to 90 minutes after drug initiation.

  2. Echocardiography

    Echocardiographic measures of systolic and diastolic heart function.

    Time frame: From 0 minutes to 90 minutes after drug initiation

  3. Changes in mixed venous saturation

    Changes in mixed venous saturation (in per cent) from baseline until the end of dobutrex or placebo infusion.

    Time frame: From 0 minutes to 90 minutes after drug initiation

  4. norepinephrine requirement

    The amount of norepinephrinem(mg) required to maintain adequate systemic blood pressure during the infusion period of dobutrex and placebo

    Time frame: From 0 minutes to 90 minutes after drug initiation

  5. Central venous pressure

    Changes in CVP from baseline until 90 minutes of study drug or placebo infusion.

    Time frame: From 0 minutes to 90 minutes after drug initiation

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01375335
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Jun 17, 2011
Start date
Jun 2011
Primary completion
Aug 2013
Last update
Aug 7, 2013

Study contacts

Erik Sloth, Professor
study chair · Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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