IHD constitutes 30% of patients who undergo surgery each year in the united states.One way to restore blood flow is CABG.Which leads to the release of inflammatory factors.This is a randomized clinical trial study , to evaluate selenium effect on inflammatory factors in patients undergoing cardiac surgery.The patients with normal levels of selenium are studied by randomly selecting a card in one of two groups receiving selenium and placebo.Before induction of anesthesia in selenium group 600µg selenium and in control group equivalent distilled water injected.in both groups induction done with similar values midazolam,sufentanyl and cis atra.in all patients,TNF-α,CRP,IL-6 were measured before induction,immediately after CPB,24 and 48 hours after surgery. Finally the amount of inflammatory factors in two groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040813456N3
Registration date:2015-04-25, 1394/02/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Abbas Sedighinejad
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 132 5712
Email address
a_sedighinejad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University Of Medical Sciences
Expected recruitment start date
2015-06-09, 1394/03/19
Expected recruitment end date
2015-12-10, 1394/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment Effect of selenium injection on plasma level of TNF-α, IL-6, WBC, CRP, Glucose following CABG
Public title
Effect of selenium injection on plasma level of TNF-α, IL-6, WBC, CRP, Glucose following CABG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 30-65 years old; ASA class 2-3 with 3 vessels occlusion and EF>40-45 % and normal preoperative level of selenium(for men:29-107µg/l and for women:27-150 µg/l ).
Exclusion criteria: The pump more than 120 minutes; need to inotropic drugs; extubation over than 8-10 hours.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
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
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193833697
Approval date
2015-01-05, 1393/10/15
Ethics committee reference number
1930474201
Health conditions studied
1
Description of health condition studied
CABG with CPB
ICD-10 code
T80.8
ICD-10 code description
Other complications following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
Tumor necrosis factor alpha
Timepoint
Before induction, immediately after CPB, 24 and 48 hours after surgery
Method of measurement
Picogram per milliliter/Elisa metod
2
Description
IL-6
Timepoint
Before induction, immediately after CPB, 24 and 48 hours after surgery
Method of measurement
Picogram per milliliter/Elisa metod
3
Description
Glucose
Timepoint
Before induction, immediately after CPB, 24 and 48 hours after surgery
Method of measurement
mg/dl/autoanalasor RA-1000
4
Description
C-Reactive Protein
Timepoint
Before induction, immediately after CPB, 24 and 48 hours after surgery
Method of measurement
Reversed passive agglutination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: Selenium group 600 µg selenium injected, before induction of anesthesia
Category
Treatment - Drugs
2
Description
Intervention 2: control groupPlacebo) equivalent distilled water injected, before induction of anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Abbas Sedighinejad
Street address
Fifteenth Khordad Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Abbas Sedighinejad
Position
Anesthesiologist
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13
Fax
+98 13 3334 5132
Email
aecguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Abbas Sedighinejad
Position
Anesthesiologist
Other areas of specialty/work
Street address
Dr.Heshmat Hospital
City
Rasht
Postal code
4193955599
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)