Skip to content

Amiodarone to reduce post-cardiopulmonary bypass systemic inflammatory response

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33778807
Enrollment
40
Registered
2005-11-15
Start date
2002-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary-artery bypass surgery (CABG) with CPB Surgery Coronary artery bypass graft (CABG)

Interventions

Placebo or Amiodarone 600 mg/day for seven days orally and 45 mg/hour intravenously (IV) for 48 hours after the start of surgery

Sponsors

Medical University of Vienna, Department of Cardiology (Austria)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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] 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

Design outcomes

Primary

MeasureTime frame
C-reactive protein concentration area under the curve (AUC) up to 48 hours after start of surgery

Secondary

MeasureTime frame
AUCs of white blood cell count (WBC), fasting blood glucose (FBG), tumour necrosis factor-alpha (TNF-alpha), interleukin 6 and interleukin 10.

Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026