Back to resultsLevosimendan Versus Dobutamine in Shock Patients
Primary Purpose
Cardiogenic Shock, Septic Shock
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Levosimendan
Dobutamine
Sponsored by
About this trial
This is an interventional treatment trial for Cardiogenic Shock focused on measuring Shock, Levosimendan, Inotropes, Dobutamine, Heart failure, Sepsis
Eligibility 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
Sites / Locations
- Intensive Care Unit, Nepean HospitalRecruiting
Outcomes
Primary Outcome Measures
Resolution of shock state
Secondary Outcome Measures
Change in cardiac functions
Full Information
NCT ID
NCT00093301
First Posted
October 5, 2004
Last Updated
June 23, 2005
Sponsor
Wentworth Area Health Services
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00093301
Brief Title
Levosimendan Versus Dobutamine in Shock Patients
Official Title
Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2004
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wentworth Area Health Services
Collaborators
Abbott
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock, Septic Shock
Keywords
Shock, Levosimendan, Inotropes, Dobutamine, Heart failure, Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Primary Outcome Measure Information:
Title
Resolution of shock state
Secondary Outcome Measure Information:
Title
Change in cardiac functions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Intensive Care Unit, Nepean Hospital
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2750
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony S McLean, MD
Phone
+61-2-47342490
Email
mcleana@wahs.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Stephen J Huang, PhD
Phone
+61-247342320
Email
huangs@wahs.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Anthony S McLean, MD
First Name & Middle Initial & Last Name & Degree
Stephen J Huang, PhD
First Name & Middle Initial & Last Name & Degree
Ian Seppelt, MD
First Name & Middle Initial & Last Name & Degree
Marek Nalos, MD
12. IPD Sharing Statement
Learn more about this trial
Levosimendan Versus Dobutamine in Shock Patients
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