Effect of prophylactic amiodarone in the prevention of postoperative atrial fibrillation after coronary artery bypass surgery in Mazandaran Heart Center
Research: Clinical Trial. Inclusion criterion: preoperative sinus rhythm.
Exclusion criteria: allergy to amiodarone or use of amiodarone in the last 6 months; history of toxicity with amiodarone; anti-arrhythmic therapy before surgery; thyroid disease; aspartate aminotransferase or alanine aminotransferase concentration 4 times higher than normal; pregnant patients; a lower rate 50; heart failure; AV block, and surgical history of lung disease and hepatitis.
Sample size: 75 double-blind study medication amiodarone and placebo groups, respectively. amiodarone drug, amiodarone vial 2 vials 2 ml ampoules equivalent to 300 mg amiodarone, the incision in the operating room during a time period of 20 minutes through a central venous catheter, and the next dose at 24 hours will receive ICUOH as Drip . Structurally similar to amiodarone and placebo injections and pills. Hospitalized for 7 days after surgery, the patients completed the study per day taken an EKG. Anesthesia in the operating room personnel without being aware of it, measure the length of stay for all patients. Of all patients sampled, measurement of left atrial size and ejection fraction, performed before discharge.
General information
Acronym
amiodarone
IRCT registration information
IRCT registration number:IRCT2014090813156N7
Registration date:2014-12-30, 1393/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-30, 1393/10/09
Registrant information
Name
Mohammad Ali Heydari Gorji
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7342
Email address
mheydarigorji@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic amiodarone in the prevention of postoperative atrial fibrillation after coronary artery bypass surgery in Mazandaran Heart Center
Public title
Effect of amiodarone in postoperative atrial fibrillation after coronary artery bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: preoperative sinus rhythm.
Exclusion criteria: allergy to amiodarone or use of amiodarone in the last 6 months; history of toxicity with amiodarone, anti-arrhythmic therapy before surgery; thyroid disease; aspartate aminotransferase or alanine aminotransferase concentration 4 times higher than normal; pregnant patients, a lower rate 50; heart failure; AV block and surgical history of lung disease and hepatitis.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Vice chancellor foe research, Mazandaran University of Medical Sciences
City
Sari
Postal code
Approval date
2014-11-19, 1393/08/28
Ethics committee reference number
844
Health conditions studied
1
Description of health condition studied
CAD in CABG
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts
Primary outcomes
1
Description
The incidence of atrial fibrillation
Timepoint
During hospitalization
Method of measurement
Monitoring
Secondary outcomes
1
Description
Hospitalization time
Timepoint
During hospitalization
Method of measurement
Monitoring and documentation
Intervention groups
1
Description
Control group: in this group use placebo (structured by normal saline serum) that similiar to Amiodarone Ampules and tablets. according to this research, anesthesia and patient do not inform about infusion, so two blind research have. in OR; two times infuse placebo and after that in ICU ward infuse drip in 24 hrs, then oral placebo are fed until discharge.
Preoperative and Postoperative atrial size and ejection fraction measured
Category
Placebo
2
Description
Amiodarone: Amiodarone vial 2 vials 2 ml ampoules equivalent to 300 mg amiodarone, the surgical incision during a time period of 20 minutes through a central venous catheter, and the next dose as DrIp ICUOH within 24 hours by weight will receive 20 mg per kg.
Preoperative and Postoperative atrial size and ejection fraction measured
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart Centre
Full name of responsible person
Kaveh Jafari
Street address
Mazandaran Heart Centre, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Centre of Mazandaran Univeristy of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Research Centre, moallem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Centre of Mazandaran Univeristy of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medial Sciences
Full name of responsible person
Kaveh Jafari
Position
M.Sc
Other areas of specialty/work
Street address
Nasibeh nursing School, Vesal street
City
Sari
Postal code
Phone
+98 911 780 7886
Fax
Email
kavehjafari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medial Sciences
Full name of responsible person
Kaveh Jafari
Position
M.Sc
Other areas of specialty/work
Street address
Nasibeh Nursing School, Vesal Street
City
Sari
Postal code
Phone
+98 911 780 7886
Fax
Email
kavehjafari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medial Sciences
Full name of responsible person
Kaveh Jafari
Position
M.Sc
Other areas of specialty/work
Street address
Nasibeh Nursing School, Vesal Street
City
Sari
Postal code
Phone
+98 911 780 7886
Fax
Email
kavehjafari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)