Levosimendan Versus Dobutamine in Shock Patients

NCT ID: NCT00093301

Last Updated: 2005-06-24

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-04-30

Brief Summary

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The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Detailed Description

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Conditions

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Cardiogenic Shock Septic Shock

Keywords

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Shock Levosimendan Inotropes Dobutamine Heart failure Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levosimendan

Intervention Type DRUG

Dobutamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Reduced left ventricular systolic function
* Hypotension
* Anuria or oligouria

Exclusion Criteria

* Less than 18 years old
* Pregnant
* Uncorrected valvular stenosis
* Hypertrophic obstructive cardiomyopathy (HOCM)
* Third degree AV block
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Wentworth Area Health Services

OTHER

Sponsor Role lead

Locations

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Intensive Care Unit, Nepean Hospital

Penrith, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Facility Contacts

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Anthony S McLean, MD

Role: primary

Stephen J Huang, PhD

Role: backup

Other Identifiers

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03/007

Identifier Type: -

Identifier Source: org_study_id