Protocol summary
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Study aim
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The effect of melatonin on inflammatory cytokines in patients undergoing coronary artery bypass graft surgery
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Design
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Randomized triple blinded clinical trial.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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In the Melatonin group patients receive 10 mg Melatonin every night two weeks before the operation
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Main outcome variables
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Serum level inflammatory cytokines
General information
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Reason for update
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Changing the title of the study its became more general
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141009019470N73
Registration date:
2018-03-07, 1396/12/16
Registration timing:
prospective
Last update:
2020-01-10, 1398/10/20
Update count:
1
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Registration date
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2018-03-07, 1396/12/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-04, 1397/01/15
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Expected recruitment end date
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2018-08-06, 1397/05/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of melatonin on inflammatory cytokines in patients undergoing coronary artery bypass graft surgery
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Public title
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The effect of melatonin on inflammatory cytokines in patients undergoing coronary artery bypass graft surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
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Age
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From 40 years old to 70 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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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.
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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patient, accessor and observer are blinded to the study.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-26, 1396/10/05
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Ethics committee reference number
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IR.SUMS.MED.REC.1396.20
Health conditions studied
1
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Description of health condition studied
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Coronary Artery Bypass Surgery
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ICD-10 code
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I25.1
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
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Description
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serum level of Inflammatory cytokines
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Timepoint
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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
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Method of measurement
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venous blood samples
Intervention groups
1
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Description
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Intervention group: Patients in the placebo group received placebo every night two weeks before the operation
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Category
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Prevention
2
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Description
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Control group:patients in the placebo group received placebo every night two weeks before the operation.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable