Cardiogenic ShockPhase 2/3NCT00093301
Levosimendan Versus Dobutamine in Shock Patients
A Phase 2/3 study testing Levosimendan and Dobutamine in people with Cardiogenic Shock and Septic Shock, run by Wentworth Area Health Services at 1 site in Australia.
Trial summary
The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Septic Shock
- What is being tested?
- Levosimendan and Dobutamine
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2004to Apr 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reduced left ventricular systolic function
- Hypotension
- Anuria or oligouria
Who cannot join
- Less than 18 years old
- Pregnant
- Uncorrected valvular stenosis
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Third degree AV block
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Intensive Care Unit, Nepean Hospital
Penrith, New South Wales, 2750
Anthony S McLean, MD, +61-2-47342490, mcleana@wahs.nsw.gov.au
Stephen J Huang, PhD, +61-247342320, huangs@wahs.nsw.gov.au
About this study
Official title: Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study
The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).
- Conditions
- Cardiogenic Shock, Septic Shock
- Being tested
- Levosimendan, Dobutamine
- Keywords
- Shock, Levosimendan, Inotropes, Dobutamine, Heart failure, Sepsis
- Medical subject headings
- Shock, Cardiogenic, Shock, Septic, Shock, Heart Failure, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
DobutamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of shock state
Secondary outcomes (1)
Change in cardiac functions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2004 (estimated)
- Study startOct 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Wentworth Area Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093301
- Sponsor's protocol ID
- 03/007
- Status last verified
- Oct 2004
- First submitted
- 5 Oct 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT00093301
- Acronym / sponsor ID
- 03/007
- Conditions
- Cardiogenic Shock, Septic Shock
- Keywords
- Shock, Levosimendan, Inotropes, Dobutamine, Heart failure, Sepsis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Wentworth Area Health ServicesUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Oct 2004
- Study completion
- Apr 2006
- First posted
- 7 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reduced left ventricular systolic function
- Hypotension
- Anuria or oligouria
Key exclusion criteria (5 listed)
- Less than 18 years old
- Pregnant
- Uncorrected valvular stenosis
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Third degree AV block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levosimendan | Drug | – |
| Dobutamine | Drug | – |
Primary outcome
Resolution of shock state
1 secondary outcome
Change in cardiac functions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levosimendan and Dobutamine in people with Cardiogenic Shock and Septic Shock, run by Wentworth Area Health Services at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of shock state. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.