- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01221116
Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
November 1, 2010 updated by: Ullevaal University Hospital
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Single center, prospective, randomized parallel-group, double-blinded study
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway, 0407
- Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- EF (ejection fraction)<40%
Exclusion Criteria:
- renal failure, liver failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1: Type of surgery
Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)
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levosimendan 0.1 microgram/kg/min) for 24 hours
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Need for inotropic agents or IABP (intra aortal balloon pump)
Time Frame: jan 2003 - dec 2008
|
jan 2003 - dec 2008
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.
Time Frame: jan 2003-dec 2008
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jan 2003-dec 2008
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Knut A Kirkebøen, MD, PhD, Ullevaal University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
October 13, 2010
First Submitted That Met QC Criteria
October 13, 2010
First Posted (Estimate)
October 14, 2010
Study Record Updates
Last Update Posted (Estimate)
November 2, 2010
Last Update Submitted That Met QC Criteria
November 1, 2010
Last Verified
January 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INSI-study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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