Protocol summary

Summary
Preventing atrial fibrillation is crucial due to decrease any side effect of admission in the hospital. It has been shown that arrhthmia prevention has an important role in decrease mortality and morbidity of patients who undergo cardiac surgery. In this study, we would like to evaluate and compare the preventive effect of Amiodarone and Lidocaine on post CABG cardiac arrhythmia. 150 patients will be randomly assigned (balanced block randomization) to three groups (A, B, and C). In group A: during the cardiopulmonary bypass and before releasing aortic cross clamp, Lidocaine (4 mg/kg) will be added to the prime. In group B and C: during the cardiopulmonary bypass and before releasing aortic cross clamp, Amiodarone (150 mg) and normal saline (5 cc) will be added to the prime, respectively. DC shock will be applied whenever it is required. Na, K, Ca, Mg, PH, and HCO3 will be evaluated before cross clamping, during CPB time, after release of aortic cross clamp, 1, 6, and 24 hours after entering the ICU. CPK will be evaluated before surgery, 1, 6, and 12 hours after entering the ICU. Outcomes: 1.patients' cardiac rhythm after release of aortic cross clamp, entering the ICU, and entering the ward by holter monitoring.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205198860N2
Registration date: 2012-05-31, 1391/03/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-05-31, 1391/03/11
Registrant information
Name
Alireza Alizadeh Ghavidel
Name of organization / entity
Rajaei Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2147
Email address
aghavidel@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Rajaei Heart Center
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Amiodarone and Lidocaine in the incidence of cardiac arrhythmia after coronary artery bypass graft surgery
Public title
Difference between Amiodarone and Lidocaine in the incidence of arrhythmia after cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Age > 18; 2. patients with coronary artery disease who need CABG surgery; 3. On-pump surgery; 4. In Dr.Ghavidel and Dr.Khamooshi's service; 5. negative history of ventricular arrhythmia before surgery. Exclusion criteria: 1. Requiring concomitant surgery; 2. Reject to enter to this study; 3. Any known history of sensitivity to Lidocaine or Amiodarone.
Age
From 18 years old
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)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rajaei Heart Center
Street address
Valiasr Ave, Niyayesh Blvd
City
Tehran
Postal code
Approval date
2009-08-04, 1388/05/13
Ethics committee reference number
8811248009

Health conditions studied

1

Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I20-I25
ICD-10 code description
Ischemic Heart Disease

Primary outcomes

1

Description
Incidence of cardiac arrhythmia after cardiac surgery
Timepoint
After removal of aortic cross clamp, during ICU stay, during ward stay
Method of measurement
Holter monitoring

Secondary outcomes

1

Description
Mortality rate
Timepoint
30 days after operation
Method of measurement
Interview, phone call

Intervention groups

1

Description
Treatment (A): Lidocaine (4 mg/kg) will be added to the prime before removal of aortic cross clamp
Category
Prevention

2

Description
Treatment (B): Amiodarone (150 mg) will be added to the prime before removal of aortic cross clamp.
Category
Prevention

3

Description
Control (C): Normal saline (5 cc) will be added to the pomp solution before removal of aortic cross clamp.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaei Heart Center
Full name of responsible person
Dr. Alireza Alizadeh Ghavidel
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Dr. Majid Haghjoo
Street address
Valiasr Ave. Nyayesh Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaei Heart Center
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
Rajaei Heart Center
Full name of responsible person
Dr. Alireza Alizadeh Ghavidel
Position
Assisstant professor
Other areas of specialty/work
Street address
Valiasr Ave, Nyayesh Blvd.
City
Tehran
Postal code
Phone
+98 21 2392 2147
Fax
Email
aaghavidel@gmail.com, aghavidel@rhc.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Dr. Alireza Alizadeh Ghavidel
Position
Assisstant Professor of cardiac surgery
Other areas of specialty/work
Street address
Valiasr Ave, Nyayesh Blvd.
City
Tehran
Postal code
Phone
+98 21 2392 2147
Fax
Email
aaghavidel@gmail.com, aghavidel@rhc.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Dr. Alireza Alizadeh Ghavidel
Position
Assisstant Professor
Other areas of specialty/work
Street address
Valiasr Ave, Nyayesh Blvd.
City
Tehran
Postal code
Phone
+98 21 2392 2147
Fax
Email
aaghavidel@gmail.com, aghavidel@rhc.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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