Study Stopped
Insufficient patient eligible for recruitment
The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedAugust 7, 2013
August 1, 2013
2.2 years
June 14, 2011
August 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac output
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 Outcomes (5)
Mean pulmonary artery pressure
From 0 to 90 minutes after drug initiation.
Echocardiography
From 0 minutes to 90 minutes after drug initiation
Changes in mixed venous saturation
From 0 minutes to 90 minutes after drug initiation
norepinephrine requirement
From 0 minutes to 90 minutes after drug initiation
Central venous pressure
From 0 minutes to 90 minutes after drug initiation
Study Arms (1)
Dobutamine
EXPERIMENTALInterventions
90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized
Eligibility Criteria
You may qualify if:
- years
- Left ventricular posterior wall =/\>12mm
- Ejection fraction \> 45%
- Sinus rhythm
- Eligible for aortic valve replacement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesia & Intensive Care, Århus University Hospital
Aarhus, 8200, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Erik Sloth, Professor
Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2011
First Posted
June 17, 2011
Study Start
June 1, 2011
Primary Completion
August 1, 2013
Last Updated
August 7, 2013
Record last verified: 2013-08