ISRCTN85175364已完成不适用

EVOsimendan before Heart-Lung-Machine in coronary artery bypass graft operations

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)0 个研究点目标入组 100 人开始时间: 2008年4月11日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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)

•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

发起方

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)