Levosimendan Versus Dobutamine in Shock Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2004 by Wentworth Area Health Services.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Abbott

Information provided by:

Wentworth Area Health Services

ClinicalTrials.gov Identifier:

NCT00093301

First received: October 5, 2004

Last updated: June 23, 2005

Last verified: October 2004

History of Changes

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 2 Phase 3


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

MedlinePlus related topics: Shock

Drug Information available for: Dobutamine Dobutamine hydrochloride

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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


Shock Shock, Septic Shock, Cardiogenic Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Myocardial Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Simendan Dobutamine	Anti-Arrhythmia Agents Cardiotonic Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Protective Agents Physiological Effects of Drugs Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents

ClinicalTrials.gov processed this record on September 30, 2016

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