Evaluation of the protective effect of N-Acetyle-Cysteine versus placebo on the heart of diabetic patients undergoing CABG: a triple blind randomized clinical trial
To assess the protective effect of N-Acetyle-Cysteine versus placebo on the heart of diabetic patients undergoing CABG
Design
A triple blind randomized clinical trial
Settings and conduct
The eligible diabetic patients who will undergo CABG refer to Farshchian Heart Hospital during the study period will be enrolled into the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 45 to 75 years
Male gender
Diabetic
Candidate for undergoing CABG
Cardiac index at least 2.5 L/m2
Exclusion criteria:
Myocardial infarction after CABG
Moderate to severe Valvular disorder
Taking inotropic medication for a long time before or after surgery
Arm circumference larger than barometric cuff
Intervention groups
Intervention group: Intravenous injection of N-Acetyle-Cysteine 3 mg/kg single dose one hour before surgery.
Control group: Intravenous injection of normal saline 3 ml/kg single dose one hour before surgery.
Main outcome variables
Assessing cardiac ejection fraction before and 3 days after surgery using transthoracic echocardiography.
Assessing cardiac index before and 3 days after surgery using transthoracic echocardiography.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N202
Registration date:2017-12-31, 1396/10/10
Registration timing:registered_while_recruiting
Last update:2017-12-31, 1396/10/10
Update count:0
Registration date
2017-12-31, 1396/10/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2017-05-05, 1396/02/15
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
empty
Scientific title
Evaluation of the protective effect of N-Acetyle-Cysteine versus placebo on the heart of diabetic patients undergoing CABG: a triple blind randomized clinical trial
Public title
Evaluation of the protective effect of N-Acetyle-Cysteine versus placebo on the heart of diabetic patients undergoing CABG
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 45 to 75 years
Male gender
Diabetic
Candidate for undergoing CABG
Cardiac index at least 2.5 L/m2
Exclusion criteria:
Myocardial infarction after CABG
Moderate to severe Valvular disorder
Taking inotropic medication for a long time before or after surgery
Arm circumference larger than barometric cuff
Age
From 45 years old to 75 years old
Gender
Male
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
240
Actual sample size reached:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.UMSHA.REC.1396.77
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft
ICD-10 code
I25.70
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris
Primary outcomes
1
Description
Assessing cardiac ejection fraction
Timepoint
before and 3 days after surgery
Method of measurement
using transthoracic echocardiography
2
Description
Assessing cardiac index
Timepoint
before and 3 days after surgery
Method of measurement
using transthoracic echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous injection of N-Acetyle-Cysteine 3 mg/kg single dose one hour before surgery.
Category
Treatment - Drugs
2
Description
Control group: Intravenous injection of normal saline 3 ml/kg single dose one hour before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital
Full name of responsible person
Dr Zahra Mohammadzadeh Vijeh
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
mohammadzade84@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Zahra Mohammadzadeh Vijeh
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
mohammadzade84@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ahmad Reza Salim Bahrami
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
salimbahramidr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available