- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02275013
Levosimendan Administration and Outcome in Cardiac Surgery
October 23, 2014 updated by: Michael Sander, Charite University, Berlin, Germany
To assess the effects on outcome of levosimendan with respect to timing of its administration on the postoperative course of high-risk cardiac surgery patients in a retrospective observational study.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
159
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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Berlin, Germany, 10117
- Charité University Medicine
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cardiac surgery patients
Description
Inclusion Criteria:
- patients undergoing cardiac surgery between 2006 and 2013
- levosimendan administration within 24 hours of postoperative ICU admission
Exclusion Criteria:
- patients younger than 18
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early
Levosimendan administration within first hour of post-operative ICU admission
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Late
Levosimendan administration within 24 hours of post-operative ICU admission but after first hour
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In-hospital mortality
Time Frame: until discharge, an average of 3 weeks length of stay
|
until discharge, an average of 3 weeks length of stay
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1 year follow-up mortality
Time Frame: 1 year after surgery
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1 year after surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of mechanical ventilation
Time Frame: until discharge, an average of 3 weeks length of stay
|
until discharge, an average of 3 weeks length of stay
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Incidence of renal dysfunction
Time Frame: until discharge, an average of 3 weeks length of stay
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until discharge, an average of 3 weeks length of stay
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Incidence of renal replacement therapy
Time Frame: until discharge, an average of 3 weeks length of stay
|
until discharge, an average of 3 weeks length of stay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2006
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 23, 2014
First Submitted That Met QC Criteria
October 23, 2014
First Posted (Estimate)
October 27, 2014
Study Record Updates
Last Update Posted (Estimate)
October 27, 2014
Last Update Submitted That Met QC Criteria
October 23, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ea1-044-13b
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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