Amiodarone to reduce post-cardiopulmonary bypass systemic inflammatory response

ISRCTN	ISRCTN33778807
DOI	https://doi.org/10.1186/ISRCTN33778807
Secondary identifying numbers	EK.Nr: 078/2001

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Gottfried Heinz
Scientific

Waehringer Guertel 18-20
Vienna
1090
Austria

Study design	Prospective, double blind, placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	APPCIR
Study objectives	The study investigated the anti-inflammatory properties of Amiodarone after coronary-artery bypass surgery using cardiopulmonary bypass (CPB)
Ethics approval(s)	Ethical committee of the Medical University of Vienna
Health condition(s) or problem(s) studied	Coronary-artery bypass surgery (CABG) with CPB
Intervention	Placebo or Amiodarone 600 mg/day for seven days orally and 45 mg/hour intravenously (IV) for 48 hours after the start of surgery
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amiodarone
Primary outcome measure	C-reactive protein concentration area under the curve (AUC) up to 48 hours after start of surgery
Secondary outcome measures	AUCs of white blood cell count (WBC), fasting blood glucose (FBG), tumour necrosis factor-alpha (TNF-alpha), interleukin 6 and interleukin 10.
Overall study start date	01/04/2002
Completion date	01/03/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20-40
Key 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
Key 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] <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
Date of first enrolment	01/04/2002
Date of final enrolment	01/03/2004

Waehringer Guertel 18-20

Vienna
1090
Austria

Medical University of Vienna, Department of Cardiology (Austria)
University/education

Waehringer Guertel 18-20
Vienna
1090
Austria

"ROR"	https://ror.org/05n3x4p02

Not defined

Supported by the Austrian Science Fund (Fonds zur Förderung der Wissenschaftlichen Forschung [FWF]) (Austria) (Grant P 15152)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No