Protocol summary

Summary
One of the common complications after coronary artery bypass surgery (CABG) is arrhythmia. The most common arrhythmia in this patients is atrial fibrillation (AF). Postoperative AF can lead to hemodynamic instability, palpitation, thromboembolism, higher risk of stroke after surgery, increase length of intensive care unit (ICU) stay and consequently increased costs . So far there have been many efforts to reduce the incidence of AF in these high risk patients. In recent years, several studies have demonstrate the role of inflammation and oxidative stress in the pathogenesis of postoperative AF. Therefore, to prevent it they recommend the use of antioxidant and anti-inflammatory agents. In such cases, one of the drugs which has been used used is N-acetylcystein (NAC). It has antioxidant and anti-inflammatory properties. There are only few studies about the effects of NAC on prevention of post-operative AF after CABG, with conflicting results. This study aimed to evaluate the effects of NAC on prevention of AF after CABG surgery to reduce the incidence of this arrhythmia and its complications, consequently reduce the costs of patients hospital stay. This study is a randomized double-blinded clinical trial. Participants of this study are patients who will admit in the Mazandaran heart center for elective CABG surgery. After taking essential agreements, we will select 150 patients using randomized numerous schedule. In the intervention group, after induction of anesthesia, we will infuse 50 mg/kg NAC in 30 minutes and repeat it every day for two days after surgery. We will use normal saline infusion as placebo in the control group, in the same time interval. In addition, before and 3 days after surgery a blood sample is taken to assess serum hsCRP level. All patients will be evaluated for occurrence of any postoperative AF. Also other variables including length of ICU and hospital stay will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015040921669N1
Registration date: 2016-09-12, 1395/06/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-12, 1395/06/22
Registrant information
Name
Aria Soleimani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3332 4002
Email address
asoleimani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran Universiy of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous N-acetylcysteine on prevention of atrial fibrillation after Coronary Artery Bypass Graft surgery(CABG)
Public title
Effect of intravenous N-acetylcysteine on prevention of atrial fibrillation after Coronary Artery Bypass Graft surgery(CABG) .
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patient's willingness to participate in the study and getting informed consent from them; Non-emergency CABG surgery; Using cardiopulmonary bypass pump; No history of cardiac tachyarrhythmias before surgery (including AF); Having sinus rhythm; Hemodynamic stability (50 MAP> and heart rate between 50-110); and age between 35 and 75 years. Exclusion criteria: Heart failure patients with ejection fraction (EF) less than 30%; History of COPD, Hyperthyroidism; Occurrence of postoperative MI; Need to pacemaker post-operatively; Re-operation for any reason; Previous history of heart surgery; Use of anti-arrhythmic drugs (with the exception of beta-blockers); Using Inotropic drugs more than the usual dose (epinephrine infusion more than 0.1 mcg / kg / min and dopamine and dobutamine infuson more than 10 mcg / kg / min)
Age
From 35 years old to 75 years old
Gender
Both
Phase
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
Sari, Moalem Square
City
Sari
Postal code
4818813771
Approval date
2013-09-11, 1392/06/20
Ethics committee reference number
1392-6-20

Health conditions studied

1

Description of health condition studied
Atrial Fibrillation
ICD-10 code
148
ICD-10 code description
Atrial fibrillation and flutter

Primary outcomes

1

Description
Postoperative Atrial Fibrillation
Timepoint
72 hours after surgery and continued after discharge from the ICU
Method of measurement
By the senior nurse in open heart surgical intensive care unit prosperity and approved by the monitoring device by cardiologists

Secondary outcomes

1

Description
Serum hsCRP
Timepoint
Preoperative and postoperatively in the first and third day
Method of measurement
With Elisa method and using Vidas

Intervention groups

1

Description
Double blind clinical trial
Category
Treatment - Drugs

2

Description
In the intervention group, 50 mg of N-acetylcysteine will be administered intravenously during the procedure, 24 and 48 hours after surgery, within 30 minutes.
Category
Treatment - Drugs

3

Description
In the control group, patients will receive intravenous infusion of normal saline as placebo, intra-operatively and also 24 and 48 hours after surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Dr. Aria Soleimani
Street address
Fatemeh Zahra Hospital, artesh BLVD
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmadali Enayati
Street address
Mazandaran Heart Center, artesh BLVD
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University 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 Medical Sciences
Full name of responsible person
Dr. Aria Soleimani
Position
Assistant Professor Anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center, artesh BLVD
City
Sari
Postal code
4818813771
Phone
+98 11 3332 4002
Fax
Email
asoleimani@mazums.ac.ir, a46soleimani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Aria Soleimani
Position
Assistant Professor
Other areas of specialty/work
Street address
Mazandaran Heart Center, artesh BLVD
City
Sari
Postal code
4818813771
Phone
+98 11 3332 4002
Fax
Email
asoleimani@mazums.ac.ir , a46soleimani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Aria Soleimani
Position
Fellowship of cardiac anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center, artesh BLVD
City
Sari
Postal code
4818813771
Phone
+98 11 3332 4002
Fax
+98 11 3332 4002
Email
asoleimani@mazums.ac.ir, a46soleimani@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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