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

Completed

• Conditions: Coronary artery disease/coronary artery bypass graft operations; Circulatory System

• Registration Number: ISRCTN85175364
• Lead Sponsor: Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Haemodynamic values throughout surgery and during patient's stay in the ICU<br>2. Doses and duration of therapy with catecholamines <br>3. Echocardiographic parameter during surgery <br>4. Delta-creatinine clearance before and after surgery <br>5. Horowitz (oxygenation) index, measured every 12 hours during patient's stay in the ICU<br>6. Serum lactate values during surgery and patient's stay in the ICU <br>7. Survival after 30 days and after 6 months <br>8. Incidence and frequencies of haemodialysis during patient's stay in the ICU <br>9. Incidence and frequencies of hemodialysis after fulfilling ICU discharge criteria up to hospital discharge <br>10. Quality of life 6 months after surgery