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NCT00093301 Clinical Trial

Levosimendan Versus Dobutamine in Shock Patients

Septic Shock Clinical Trial

Official title:
Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00093301
Other study ID # 03/007
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received October 5, 2004
Last updated June 23, 2005
Start date October 2004
Est. completion date April 2006

Study information
Verified date October 2004
Source Wentworth Area Health Services
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Levosimendan

• Dobutamine

Locations
Country Name City State
Australia Intensive Care Unit, Nepean Hospital Penrith New South Wales

Sponsors (2)
Lead Sponsor Collaborator
Wentworth Area Health Services Abbott

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resolution of shock state
Secondary Change in cardiac functions
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