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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

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Postoperative, Dobutamine, Inotropes, Stunning, Heart failure

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01375335

First Posted

June 14, 2011

Last Updated

August 6, 2013

Sponsor

University of Aarhus

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

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

Learn more about this trial

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

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