Effect of selenium versus placebo on clinical symptoms after coronary artery bypass graft in patients with coronary artery stenosis: a double-blind randomized clinical trial
To assess the effect of selenium versus placebo on clinical symptoms after coronary artery bypass graft in patients with coronary artery stenosis
Design
This is a double-blind randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with coronary artery stenosis who will refer to Farshchian Heart Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 75 years
Coronary artery stenosis
An indication of coronary artery bypass graft
Exclusion criteria:
Emergency patients
A history of heart surgery
Valvular disease
Intervention groups
Intervention group: Intravenous injection of selenium 100 mic gr single dose 10 min before detaching the pump
Control group: Intravenous injection of distilled water 2 ml single dose 10 min before detaching the pump us
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
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of selenium versus placebo on clinical symptoms after coronary artery bypass graft in patients with coronary artery stenosis: a double-blind randomized clinical trial
Public title
Effect of selenium versus placebo on clinical symptoms after coronary artery bypass graft in patients with coronary artery stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 75 years
Coronary artery stenosis
Indication of coronary artery bypass graft
Exclusion criteria:
Emergency patients
A history of heart surgery
Valvular disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots
Blinding (investigator's opinion)
Double 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. Therefore, the trial will be run as double 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
2015-04-11, 1394/01/22
Ethics committee reference number
UMSHA.REC.1394.31
Health conditions studied
1
Description of health condition studied
Coronary artery stenosis
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Assessing dysrhythmia
Timepoint
Every 6 hours for 24 hours
Method of measurement
Using a monitor
Secondary outcomes
1
Description
Assessing inotrope usage
Timepoint
24 hours after surgery
Method of measurement
With checking patient's medical record
Intervention groups
1
Description
Intervention group: Intravenous injection of selenium 100 mic gr single dose 10 min before detaching the pump
Category
Treatment - Drugs
2
Description
Control group: Intravenous injection of distilled water 2 ml single dose 10 min before detaching the pump us
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital
Full name of responsible person
Sina Monazami Tabar
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
sinamt@outlook.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
Hamadan University of Medical Sciences, 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
Sina Monazami Tabar
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
afarhanchi1970@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Afshin Farahanchi
Position
Anesthesiologist
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
afarhanchi1970@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