Levosimendan Versus Dobutamine in Shock Patients

This study is currently recruiting participants.

Verified by Wentworth Area Health Services, October 2004

Sponsors and Collaborators:	Wentworth Area Health Services Abbott
Information provided by:	Wentworth Area Health Services
ClinicalTrials.gov Identifier:	NCT00093301

Purpose

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

Condition	Intervention	Phase
Cardiogenic Shock Septic Shock	Drug: Levosimendan Drug: Dobutamine	Phase II Phase III

Drug Information available for: Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate Levosimendan Simendan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study

Further study details as provided by Wentworth Area Health Services:

Primary Outcome Measures:

Resolution of shock state

Secondary Outcome Measures:

Change in cardiac functions

Estimated Enrollment:	40
Study Start Date:	October 2004
Estimated Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093301

Locations

Australia, New South Wales
Intensive Care Unit, Nepean Hospital	Recruiting
Penrith, New South Wales, Australia, 2750
Contact: Anthony S McLean, MD +61-2-47342490 mcleana@wahs.nsw.gov.au
Contact: Stephen J Huang, PhD +61-247342320 huangs@wahs.nsw.gov.au
Principal Investigator: Anthony S McLean, MD
Sub-Investigator: Stephen J Huang, PhD
Sub-Investigator: Ian Seppelt, MD
Sub-Investigator: Marek Nalos, MD

Sponsors and Collaborators

Wentworth Area Health Services

Abbott

More Information

Study ID Numbers:	03/007
Study First Received:	October 5, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00093301
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Wentworth Area Health Services:

Shock
Levosimendan
Inotropes

Dobutamine
Heart failure
Sepsis

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Heart Failure
Heart Diseases
Shock, Cardiogenic
Myocardial Ischemia
Vascular Diseases
Ischemia
Dobutamine

Simendan
Inflammation
Sepsis
Shock
Critical Illness
Shock, Septic
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Cardiotonic Agents
Sympathomimetics
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Infection

Protective Agents
Pharmacologic Actions
Adrenergic Agonists
Phosphodiesterase Inhibitors
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009