Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EK.Nr: 078/2001
Study information
Scientific title
Acronym
APPCIR
Study hypothesis
The study investigated the anti-inflammatory properties of Amiodarone after coronary-artery bypass surgery using cardiopulmonary bypass (CPB)
Ethics approval
Ethical committee of the Medical University of Vienna
Study design
Prospective, double blind, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/04/2002
Overall trial end date
01/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20-40
Participant 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
Recruitment start date
01/04/2002
Recruitment end date
01/03/2004
Locations
Countries of recruitment
Austria
Trial participating centre
Waehringer Guertel 18-20
Vienna
1090
Austria
Funders
Funder type
Not defined
Funder name
Supported by the Austrian Science Fund (Fonds zur Förderung der Wissenschaftlichen Forschung [FWF]) (Austria) (Grant P 15152)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17400977
Publication citations
-
Results
Karth GD, Buberl A, Nikfardjam M, Meyer B, Wollenek G, Grimm M, Lassnigg A, Brannath W, Hiesmayr M, Heinz G, Role of amiodarone on the systemic inflammatory response induced by cardiac surgery: proinflammatory actions., Can J Anaesth, 2007, 54, 4, 262-268, doi: 10.1007/BF03022770.