Condition category
Surgery
Date applied
14/11/2005
Date assigned
15/11/2005
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gottfried Heinz

ORCID ID

Contact details

Waehringer Guertel 18-20
Vienna
1090
Austria

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 measures

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

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

Sponsor information

Organisation

Medical University of Vienna, Department of Cardiology (Austria)

Sponsor details

Waehringer Guertel 18-20
Vienna
1090
Austria

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17400977

Publication citations

  1. 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.

Additional files

Editorial Notes