To evaluate the effect of melatonin on interleukin 17A & interleukin 17F and interleukin 21 in patients undergoing coronary artery bypass grafting surgery
Design
Randomized triple blinded clinical trial.
Settings and conduct
42 patients undergoing coronary artery bypass grafting(CABG) in Namazi hospital, Shiraz, Iran randomly divided into two groups of Melatonin or placebo. In the Melatonin group patients receive 10 mg Melatonin every night two weeks before the operation and patients in the placebo group received placebo every night two weeks before the operation. For evaluating serum level of interleukin 17A & interleukin 17F and interleukin 21 in the both groups 4 venous blood samples taken from patients (two weeks before administration of melatonin, in the operating room before induction of anesthesia, 6 hours after declamping in the ICU and 48 hours after off pump), samples will have tested with human Th cytokine panel (13-plex), biolegend, USA by “bead-based assay” method & the level of interleukins in different phases: the effect of melatonin on inflammatory factors level will compare in case and control groups.
Participants/Inclusion and exclusion criteria
42 patients who are candidate for elective CABG with age between 40-75 years old and ASA class <III; pump time less than 90 min; graft number between 2 to 6.
Exclusion criteria: pregnancy and breast feeding; local or systemic infection; hyper sensitivity; redo surgery; surgery during last 6 months; collagen vascular disease; immunosuppressive disease; heart failure with ejection fraction less than 35%; recent cardiovascular event; un controlled HTN; renal failure; liver failure; alcohol abuser; malignancy; simultaneously valvular heart surgery.
Intervention groups
In the Melatonin group patients receive 10 mg Melatonin every night two weeks before the operation
Main outcome variables
serum level of interleukin 17A & interleukin 17F and interleukin 21
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N73
Registration date:2018-03-07, 1396/12/16
Registration timing:prospective
Last update:2018-03-07, 1396/12/16
Update count:1
Registration date
2018-03-07, 1396/12/16
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of melatonin on interleukin 17A & interleukin 17F and interleukin 21 in patients undergoing coronary artery bypass grafting surgery
Public title
Effect of melatonin on interleukin 17A & interleukin 17F and interleukin 21 in patients undergoing coronary artery bypass grafting surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidate for elective CABG with age between 40-75 years old and ASA class <III; pump time less than 90 min; graft number between 2 to 6.
Exclusion criteria:
pregnancy and breast feeding; local or systemic infection; hyper sensitivity; redo surgery; surgery during last 6 months; collagen vascular disease; immunosuppressive disease; heart failure with ejection fraction less than 35%; recent cardiovascular event; un controlled HTN; renal failure; liver failure; alcohol abuser; malignancy; simultaneously valvular heart surgery.
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
1
For assessing serum level of interleukin 17A & interleukin 17F and interleukin 21 in patients blood sample will be taken.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
patient, accessor and observer are blinded to the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2017-12-26, 1396/10/05
Ethics committee reference number
IR.SUMS.MED.REC.1396.20
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
serum level of interleukin 17A & interleukin 17F and interleukin 21
Timepoint
Two weeks before administration of melatonin, in the operating room before induction of anesthesia, 6 hours after declamping in the ICU and 48 hours after off pump
Method of measurement
venous blood samples
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the placebo group received placebo every night two weeks before the operation
Category
Prevention
2
Description
Control group:patients in the placebo group received placebo every night two weeks before the operation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Marzieh Ghasemi
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
mrymghasemi1989dec@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Ghasemi
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
mrymghasemi1989dec@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Jouybar
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
joybarr@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in English Teaching, BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Others
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
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