ISRCTN85175364CompletedNot Applicable
EVOsimendan before Heart-Lung-Machine in coronary artery bypass graft operations
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)0 sites100 target enrollmentStarted: April 11, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Amended as of 08/05/2009:
- •Point seven below is no longer an inclusion criteria and should be disregarded.
- •Initial information at time of registration:
- •1. Offered patient information and obtained informed consent
- •2. Aged over 18 years old
- •3. Negative pregnancy test or anamnestically more than two years post-menopausal
- •4. No participation in another drug study according to the pharmaceutical law
- •5. Patients undergoing elective coronary artery bypass graft-surgery because of ischaemic cardiomyopathy with or without heart valve repair
- •6. Left ventricular ejection fraction less than or equal to 30%
- •7. Compensated renal insufficiency (creatinine greater than 1.14 mg/dl)
Exclusion Criteria
- •Amended as of 08/05/2009:
- •The following point has been amended:
- •10. Therapy with oral antidiabetics discontinued at least 36 hours before surgery
- •Initial information at time of registration:
- •1. Age under 18 years old
- •2. Pregnancy or lactation
- •3. Lacking willingness to save and hand out pseudonymised data within the study
- •4. A patient is admittted to an institution because of an official or medical order (according to German Medicines Act [AMG] Sectoin 40 (1) 4)
- •5. Liver disease (Child B or C cirrhosis, acute disease, End-Stage Liver Disease [MELD] score greater than 17)
- •6. Recent oesophageal or upper airway surgery
- •7. Severe oesophageal disease
- •8. Severe disease of the upper airways
- •9. Neurological/psychiatric disease
- •10. Therapy with oral antidiabetics
- •11. Infection with human immunodeficiency virus (HIV)
- •12. Active hepatitis B or C
- •13. Unclear history of alcohol related disorder
Investigators
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