Levosimendan Versus Dobutamine in Shock Patients

This study is currently recruiting participants.

Verified by Wentworth Area Health Services, October 2004

First Received: October 5, 2004 Last Updated: June 23, 2005 History of Changes

Sponsor:	Wentworth Area Health Services
Collaborator:	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

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

Resource links provided by NLM:

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

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	03/007
Study First Received:	October 5, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00093301 History of Changes
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

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Cardiotonic Agents
Myocardial Ischemia
Physiological Effects of Drugs
Infection
Adrenergic Agonists
Simendan
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Myocardial Infarction

Systemic Inflammatory Response Syndrome
Heart Diseases
Shock, Cardiogenic
Adrenergic beta-Agonists
Sympathomimetics
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Dobutamine
Pharmacologic Actions
Inflammation
Sepsis
Phosphodiesterase Inhibitors
Shock

ClinicalTrials.gov processed this record on February 08, 2010