Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Levosimendan Versus Dobutamine in Shock Patients

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.
 
ClinicalTrials.gov Identifier: NCT00093301
Recruitment Status : Unknown
Verified October 2004 by Wentworth Area Health Services.
Recruitment status was:  Recruiting
First Posted : October 7, 2004
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Abbott
Information provided by:
Wentworth Area Health Services

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Septic Shock Drug: Levosimendan Drug: Dobutamine Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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
Study Start Date : October 2004
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Resolution of shock state

Secondary Outcome Measures :
  1. Change in cardiac functions

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 0 Years
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00093301    
Other Study ID Numbers: 03/007
First Posted: October 7, 2004    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 2004
Keywords provided by Wentworth Area Health Services:
Shock
Levosimendan
Inotropes
 Dobutamine
Heart failure
Sepsis
Additional relevant MeSH terms:
Layout table for MeSH terms
Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Infarction
Ischemia
Necrosis
Simendan
Dobutamine
Cardiotonic Agents
Vasodilator Agents
 Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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
Neurotransmitter Agents