Protocol summary

Summary
In a double-blind randomized clinical trial, 60 elective CABG patients with EF < 50% will evaluated. The patients will numbered according to their reference to the Heart Center of Mazandaran (Iran) and their arrangements in the operation list. They will be randomly allocated to 2 groups of 30 by a computer program to receive either GIK (group G) or NAC (group N).). In group G, 10 cc/h of GIK solution will infuse constantly during the surgery. Group N will injected with a cardioplegic solution containing 200 mg NAC. Normal saline will used as placebo in both groups (injected in group G and infused constantly in group N) to prevent the surgical team form identifying the drugs. A cardiopulmonary bypass pump will used for all cases in both groups.subjects will excluded in case of requiring intra-aortic balloon pump during the operation, prolonged cross-clamp period of 1.5 hours or more, and sensitivity to NAC. EF, Frequency of arrhythmia, need for inotropic drugs during and after the operation, need for shock and pacemaker, commencement of normal heart rhythm, postoperative levels of cardiac enzymes, ECG changes, central venous pressure (CVP), and duration of hospital and intensive care unit (ICU) stay wil bel also recorded and compared between the 2 groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211062883N3
Registration date: 2012-11-30, 1391/09/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-30, 1391/09/10
Registrant information
Name
Mohammadreza Habibi
Name of organization / entity
Mazandarn University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 3023
Email address
mhabibi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran Uiversity of Medical Sciences and Health Services Deputy of Research
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of cardioprotective effects of “N-acetylcysteine” to cardioplegia and “glucose-insulin-potassium” during coronary artery bypass grafting in patient candidate for CABG
Public title
Protecting effect of N-acetylcysteine on myocard during CABG
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who candidate for CABG with EF below 50% at Mazandaran Heart Center Exclusion critera:Valvular heart diseases; renal failure; liver disease; cross clamp time more than 1:30 min & use of intraaotric baloon pomp
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
serah Jouibar, Valiasr Ave.
City
Sari
Postal code
Approval date
2011-01-19, 1389/10/29
Ethics committee reference number
89128

Health conditions studied

1

Description of health condition studied
Atherosclerotic cardiovascular disease
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease

Primary outcomes

1

Description
ejection fraction of LV
Timepoint
before operation & 5 day after operation
Method of measurement
echocardiograph

Secondary outcomes

1

Description
arhythmia
Timepoint
during operation & ICU stay
Method of measurement
monitor

Intervention groups

1

Description
Control group: infution of GIK during operation
Category
Treatment - Drugs

2

Description
Intervention group: injetion of N Acetylcistein with cardiopelagic solution
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemezahra Hospital
Full name of responsible person
Dr. Mohammadreza Habibi
Street address
Artesh Blv.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran Uiversity of Medical Sciences and Health Services
Full name of responsible person
Ahmad Ali Enayati
Street address
Deputy of Research, Moalem sq
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran Uiversity of Medical Sciences and Health Services
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. Mohammadreza Habibi
Position
Assistant Professor; Fellowship of Cadiac Anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center; fattemeh alzahra Hos. Sari
City
Sari
Postal code
Phone
+98 15 1222 3023
Fax
Email
mohammadreza.habibi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Habibi
Position
Assistant Professor; Fellowship of Cadiac Anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center; fattemeh alzahra Hos.
City
Sari
Postal code
Phone
+98 15 1222 3023
Fax
Email
mohammadreza.habibi@gmail.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Habibi
Position
Assistant Professor; Fellowship of Cadiac Anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center; fattemeh alzahra Hos.
City
Sari
Postal code
Phone
+98 15 1222 3023
Fax
+98 15 1222 4002
Email
mohammareza.habibi@gmail.com
Web page address
www.mazums.ac.ir

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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