The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
Primary Purpose
Heart Failure
Status
Suspended
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dobutamine
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Postoperative, Dobutamine, Inotropes, Stunning, Heart failure
Eligibility 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
Sites / Locations
- Department of Anaesthesia & Intensive Care, Århus University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dobutamine
Arm Description
Outcomes
Primary Outcome Measures
Cardiac output
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
Changes in pulmonary artery pressure (mmHg) from start of study drug or placebo infusion until 90 minutes after the start.
Echocardiography
Echocardiographic measures of systolic and diastolic heart function.
Changes in mixed venous saturation
Changes in mixed venous saturation (in per cent) from baseline until the end of dobutrex or placebo infusion.
norepinephrine requirement
The amount of norepinephrinem(mg) required to maintain adequate systemic blood pressure during the infusion period of dobutrex and placebo
Central venous pressure
Changes in CVP from baseline until 90 minutes of study drug or placebo infusion.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01375335
Brief Title
The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
Official Title
The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Suspended
Why Stopped
Insufficient patient eligible for recruitment
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Postoperative, Dobutamine, Inotropes, Stunning, Heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dobutamine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized
Primary Outcome Measure Information:
Title
Cardiac output
Description
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 Outcome Measure Information:
Title
Mean pulmonary artery pressure
Description
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.
Title
Echocardiography
Description
Echocardiographic measures of systolic and diastolic heart function.
Time Frame
From 0 minutes to 90 minutes after drug initiation
Title
Changes in mixed venous saturation
Description
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
Title
norepinephrine requirement
Description
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
Title
Central venous pressure
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Sloth, Professor
Organizational Affiliation
Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anaesthesia & Intensive Care, Århus University Hospital
City
Århus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
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The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement
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