MedDataX Logo

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

NCT ID: NCT01375335

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Postoperative Dobutamine Inotropes Stunning Heart failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dobutamine

Group Type EXPERIMENTAL

Dobutamine

Intervention Type DRUG

90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dobutamine

90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erik Sloth, Professor

Role: STUDY_CHAIR

Department of Anaesthesia & Intensive Care, Århus Univerisity Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anaesthesia & Intensive Care, Århus University Hospital

Aarhus, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1818

Identifier Type: -

Identifier Source: org_study_id