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The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).
Cardiogenic Shock
Septic Shock
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Drug: Levosimendan
Drug: Dobutamine
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Phase II
Phase III
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U.S. FDA Resources
| Study Type: |
Interventional |
| Study Design: |
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
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| Official Title: |
Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study |
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 |
| Ages Eligible for Study: |
18 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093301
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| Intensive Care Unit, Nepean Hospital |
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| Penrith, New South Wales, Australia, 2750 |
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| Contact: Anthony S McLean, MD 61-2-47342490 mcleana@wahs.nsw.gov.au |
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| Contact: Stephen J Huang, PhD 61-247342320 huangs@wahs.nsw.gov.au |
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| Principal Investigator: Anthony S McLean, MD |
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| Sub-Investigator: Stephen J Huang, PhD |
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| Sub-Investigator: Ian Seppelt, MD |
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| Sub-Investigator: Marek Nalos, MD |
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| Wentworth Area Health Services |
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| Abbott |
|
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| Intensive Care Unit, Nepean Hospital |
|
|
| 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 |
|
| Wentworth Area Health Services |
|
| Abbott |
| Study ID Numbers: |
03/007 |
| First Received: |
October 5, 2004 |
| Last Updated: |
June 23, 2005 |
| ClinicalTrials.gov Identifier: |
NCT00093301 |
| 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 | | Study placed in the following topic categories:
| Systemic Inflammatory Response Syndrome |
| Bacterial Infections |
| Heart Failure |
| Heart Diseases |
| Shock, Cardiogenic |
| Myocardial Ischemia |
| Vascular Diseases |
| Ischemia |
| Dobutamine | |
|
| Simendan |
| Inflammation |
| Mycoses |
| Sepsis |
| Shock |
| Critical Illness |
| Shock, Septic |
| Infarction |
| Myocardial Infarction | | Additional relevant MeSH terms:
| Shock, Septic |
| Vasodilator Agents |
| Neurotransmitter Agents |
| Molecular Mechanisms of Pharmacological Action |
| Adrenergic Agents |
| Adrenergic beta-Agonists |
| Cardiotonic Agents |
| Sympathomimetics |
| Physiological Effects of Drugs |
| Enzyme Inhibitors | |
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| Cardiovascular Agents |
| Infection |
| Protective Agents |
| Adrenergic Agonists |
| Pharmacologic Actions |
| Pathological Conditions, Signs and Symptoms |
| Phosphodiesterase Inhibitors |
| Pathologic Processes |
| Bacterial Infections and Mycoses |
| Autonomic Agents | |
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