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

This study has suspended participant recruitment.
(Insufficient patient eligible for recruitment)
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01375335
First received: June 14, 2011
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: Dobutamine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Cardiac output [ Time Frame: From 0 to 90 minutes after drug initiation ] [ Designated as safety issue: No ]
    Change in cardiac output (l/min) from initiation of study drug or placebo until 90 minutes of infusion.


Secondary Outcome Measures:
  • Mean pulmonary artery pressure [ Time Frame: From 0 to 90 minutes after drug initiation. ] [ Designated as safety issue: No ]
    Changes in pulmonary artery pressure (mmHg) from start of study drug or placebo infusion until 90 minutes after the start.

  • Echocardiography [ Time Frame: From 0 minutes to 90 minutes after drug initiation ] [ Designated as safety issue: No ]
    Echocardiographic measures of systolic and diastolic heart function.

  • Changes in mixed venous saturation [ Time Frame: From 0 minutes to 90 minutes after drug initiation ] [ Designated as safety issue: No ]
    Changes in mixed venous saturation (in per cent) from baseline until the end of dobutrex or placebo infusion.

  • norepinephrine requirement [ Time Frame: From 0 minutes to 90 minutes after drug initiation ] [ Designated as safety issue: Yes ]
    The amount of norepinephrinem(mg) required to maintain adequate systemic blood pressure during the infusion period of dobutrex and placebo

  • Central venous pressure [ Time Frame: From 0 minutes to 90 minutes after drug initiation ] [ Designated as safety issue: No ]
    Changes in CVP from baseline until 90 minutes of study drug or placebo infusion.


Estimated Enrollment: 10
Study Start Date: June 2011
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375335

Locations
Denmark
Department of Anaesthesia & Intensive Care, Århus University Hospital
Århus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Erik Sloth, Professor Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01375335     History of Changes
Other Study ID Numbers: 1818
Study First Received: June 14, 2011
Last Updated: August 6, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Postoperative
Dobutamine
Inotropes
Stunning
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014