Coronary artery disease/coronary artery bypass graft operations Circulatory System Coronary artery disease/coronary artery bypass graft operations
Conditions
Interventions
Levosimendan (Simdax®) group: continuous application of levosimendan at 0.1 µg/kg body weight/min (concentration of the applied solution: 250 µg/ml levosimendan, 5% glucose), cumulative dose: 72 µg/kg
Sponsors
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Sepsis-related Organ Failure Assessment (SOFA) score to describe organ dysfunction/failure. The SOFA score will be measured daily during the patient's stay in the Intensive Care Unit (ICU). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Haemodynamic values throughout surgery and during patient's stay in the ICU 2. Doses and duration of therapy with catecholamines 3. Echocardiographic parameter during surgery 4. Delta-creatinine clearance before and after surgery 5. Horowitz (oxygenation) index, measured every 12 hours during patient's stay in the ICU 6. Serum lactate values during surgery and patient's stay in the ICU 7. Survival after 30 days and after 6 months 8. Incidence and frequencies of haemodialysis during patient's stay in the ICU 9. Incidence and frequencies of hemodialysis after fulfilling ICU discharge criteria up to hospital discharge 10. Quality of life 6 months after surgery | — |
Countries
Germany
Outcome results
None listed