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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: Sepsis Shock
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

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, Cardiogenic
Shock, Septic
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Simendan
Dobutamine
 Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on May 16, 2013