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Levosimendan Versus Dobutamine in Shock Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2004 by Wentworth Area Health Services.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00093301
First Posted: October 7, 2004
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by:
Wentworth Area Health Services
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 5, 2004
First Posted: October 7, 2004
Last Update Posted: December 9, 2005
Last Verified: October 2004

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
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Arrhythmia Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors