Protocol summary

Summary
Postoperative atrial fibrillation (AF) is the most frequent arrhythmia after cardiac surgery. It is associated with cerebrovascular accidents, hypotension, pulmonary oedema, longer hospital stays, increased cost of the procedure, and mortality. A total of 240 consecutive patients undergoing cardiac surgery in our centre between February 2010 and April 2010 were screened for eligibility. To be included in the study, patients needed to be referred for primary elective coronary artery and/or valve surgery, 18 years of age and in normal sinus rhythm. Exclusion criteria included prior coronary revascularization or heart valve surgery, emergency surgery, New York Heart Association class III or IV congestive heart failure, history of AF, hyperthyroidism, inflammatory diseases except coronary artery disease, infection, a left atrium size .70 mm, electrolyte imbalance, age ,18 years old, and ejection fraction ,0.25. The aim of this prospective, randomized, double-blind, placebo controlled study was to assess the effects of in the prevention of the postoperative AF. Patient take NAC from 48 before till 72 hours after surgery and control group take placebo . After completion of the surgical procedure, patients were admitted to the intensive care unit and when their haemodynamic and respiratory functions were stable, they were transferred to the wards. Rhythm was monitored continuously during the operation and during the first 2 postoperative days in the intensive care unit.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008134561N1
Registration date: 2011-05-29, 1390/03/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-29, 1390/03/08
Registrant information
Name
Kamran Ghasemi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 9899
Email address
ghasemik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiac research center of Tabriz university of medical sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-acetylcysteine on preventation of postcardiac surgery atrial fibrillation
Public title
Effect of N-acetylcysteine on preventation of postcardiac surgery atrial fibrillation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: primary elective coronary artery and/or valve surgery, older than 18 years of age in normal sinus rhythm. Exclusion criteria: prior coronary revascularization or heart valve surgery, emergency surgery, New York Heart Association class III or IV congestive heart failure, history of AF, hyperthyroidism, inflammatory diseases except coronary artery disease, infection, a left atrium size 70 mm, electrolyte imbalance, and ejection fraction 0.25
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 240
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
Tabriz University of Medical Sciences
Street address
Daneshgah St
City
Tabriz
Postal code
5166615573
Approval date
2010-05-29, 1389/03/08
Ethics committee reference number
5/4/1604

Health conditions studied

1

Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter

Primary outcomes

1

Description
Postoperative atrial fibrillation
Timepoint
before and up to 48h after surgery
Method of measurement
ECG holtermonitoring

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group take 1200mg tab q12h NAC from 48 before till 72 hour after surgery
Category
Prevention

2

Description
Control group take placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Babak Kazemi
Street address
Imam Khomeini St. Daneshgah St. Near Imam Khomeini Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cardiac Research Center of Tabriz Universityof Medical sciences
Full name of responsible person
Babak Kazemi
Street address
Imam Khomeini St, Daneshgah St, Near Imam Khomeini Hospital
City
Tabriz
Grant name
105006
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cardiac Research Center of Tabriz Universityof 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
Cardiac Research Center of Tabriz UniversityOf Medical Sciences
Full name of responsible person
Babak Kazemi
Position
Cardiologist
Other areas of specialty/work
Street address
Imam Khomeini St, Daneshgah St, Near Imam Khomeini Hospital
City
Tabriz
Postal code
5166615573
Phone
+98 41 1337 2958
Fax
+98 41 1337 2919
Email
bkazemia1966 @yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Cardiac Research Center of Tabriz UniversityOf Medical Sciences
Full name of responsible person
Babak Kazemi
Position
Cardiologist
Other areas of specialty/work
Street address
Imam Khomeini St, Daneshgah St, Near Imam Khomeini Hospital
City
Tabriz
Postal code
5166615573
Phone
+98 41 1337 2958
Fax
+98 41 1337 2919
Email
BKAZEMI1966@YAHOO.COM
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Cardiac Research Center of Tabriz UniversityOf Medical Sciences
Full name of responsible person
Babak Kazemi
Position
Cardiologist
Other areas of specialty/work
Street address
Imam Khomeini St, Daneshgah St, Near Imam Khomeini Hospital
City
Tabriz
Postal code
5166615573
Phone
+98 41 1337 2958
Fax
+98 41 1337 2919
Email
BKAZEMI1966@YAHOO.COM
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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