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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00093301




Registration number
NCT00093301
Ethics application status
Date submitted
5/10/2004
Date registered
7/10/2004
Date last updated
24/06/2005

Titles & IDs
Public title
Levosimendan Versus Dobutamine in Shock Patients
Scientific title
Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study
Secondary ID [1] 0 0
03/007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiogenic Shock 0 0
Septic Shock 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levosimendan
Treatment: Drugs - Dobutamine

Treatment: Drugs: Levosimendan


Treatment: Drugs: Dobutamine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Resolution of shock state
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change in cardiac functions
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Reduced left ventricular systolic function

- Hypotension

- Anuria or oligouria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Less than 18 years old

- Pregnant

- Uncorrected valvular stenosis

- Hypertrophic obstructive cardiomyopathy (HOCM)

- Third degree AV block

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Intensive Care Unit, Nepean Hospital - Penrith
Recruitment postcode(s) [1] 0 0
2750 - Penrith

Funding & Sponsors
Primary sponsor type
Other
Name
Wentworth Area Health Services
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine
in patients with unstable hemodynamics (shock).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00093301
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00093301