Amiodarone to reduce post-cardiopulmonary bypass systemic inflammatory response
- Conditions
- Coronary-artery bypass surgery (CABG) with CPBSurgeryCoronary artery bypass graft (CABG)
- Registration Number
- ISRCTN33778807
- Lead Sponsor
- Medical University of Vienna, Department of Cardiology (Austria)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Patients older than 40 years and younger than 75 years old undergoing non-emergent coronary-artery bypass surgery (CABG) with CPB were eligible for the study
1. A history of adverse events to AMIO
2. Concurrent treatment with AMIO within four months of enrolment
3. The use of antiarrhythmic therapy other than beta-receptor blockers
4. Calcium channel blockers or digitalis
5. A C-reactive protein (CRP) concentration above normal (>0.5 mg/dl)
6. A serum asparate aminotransferase or an alanine aminotransferase concentration four times the upper limit
7. Child bearing potential
8. An untreated thyroid dysfunction (thyroid-stimulating hormone [TSH] <0.01, >10 miU/ml)
9. Chronic renal failure (serum creatinine >114 µmol/l)
10. An ejection fraction <30% (determined either by nuclear, left flourescence ventriculography or echocardiography)
11. Diabetes mellitus
12. Unstable angina
13. A resting heart rate of less than 50 beats per minute
14. An active infection
15. Malignancy
16. Chronic atrial fibrillation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method C-reactive protein concentration area under the curve (AUC) up to 48 hours after start of surgery
- Secondary Outcome Measures
Name Time Method AUCs of white blood cell count (WBC), fasting blood glucose (FBG), tumour necrosis factor-alpha (TNF-alpha), interleukin 6 and interleukin 10.