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| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 5, 2004 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | October 2004 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
Resolution of shock state |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00093301 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Change in cardiac functions |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Levosimendan Versus Dobutamine in Shock Patients |
| Official Title ICMJE | Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study |
| Brief Summary | The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock). |
| Detailed Description | |
| Study Phase | Phase II, Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Enrollment ICMJE | 40 |
| Completion Date | April 2006 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | |
| Location Countries ICMJE | Australia |
| Administrative Information | |
| NCT ID ICMJE | NCT00093301 |
| Responsible Party | |
| Study ID Numbers ICMJE | 03/007 |
| Study Sponsor ICMJE | Wentworth Area Health Services |
| Collaborators ICMJE | Abbott |
| Investigators ICMJE | |
| Information Provided By | Wentworth Area Health Services |
| Verification Date | October 2004 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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