The goal of this randomized clinical trial is evaluating the effect of melatonin in cardiac biomarkers after coronary artery bypass graft (CABG).
Design
In the pilot randomized controlled trial, 100 patients undergoing coronary artery bypass grafting(CABG) will be randomly divided into two groups of Melatonin or placebo. Randomization will be done according to computerised random number generator.
Settings and conduct
100 patients undergoing coronary artery bypass grafting (CABG) in Buali-sina hospital in Qazvin, Iran, will be randomly divided into two groups of Melatonin or placebo. Participant and Investigator will be blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18 to 80 years old patients who are candidates for coronary artery bypass graft;
Informed consent to participate in the study;
Exclusion criteria:
Taking anticonvulsants - antidepressants drugs;
History of coronary artery bypass graft;
Emergency Coronary Artery Bypass Grafting;
Ejection Fraction ˂ 30.
Intervention groups
Patients will be randomly divided into two groups.
In the melatonin group: We will prescribe 3 milligram melatonin on the night before and the morning of surgery and after surgery, 3 milligram melatonin before of night's sleep for three days.
In the control group: Placebo will be prescribed on the night before and the morning of surgery and after surgery, before of night's sleep for three days.
Main outcome variables
ESR; CRP; CPK-MB; Troponin I; Arrhythmia; The number of days spent in hospital after surgery and Length of Stay for Critical Care Admissions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141006019417N2
Registration date:2018-11-30, 1397/09/09
Registration timing:prospective
Last update:2018-11-30, 1397/09/09
Update count:0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
Nahid Nasseh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8627
Email address
nnaseh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin on cardiac biomarkers after coronary artery bypass graft (CABG) surger: َa pilot clinical trial
Public title
The effect of melatonin on Cardiac Enzymes after Cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 80 years old patients who are candidates for coronary artery bypass graft;
Informed consent to participate in the study.
Exclusion criteria:
Taking anticonvulsants - antidepressants drugs;
History of coronary artery bypass graft;
Emergency Coronary Artery Bypass Grafting;
Ejection Fraction ˂ 30;
Severe pulmonary disease;
Non-sinus rhythm heart before surgery;
Having a pacemaker;
Liver disease;
Simultaneously valvular heart surgery.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly assigned to one of two study groups with the help of Random number generation software and receive the same group intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and care providers are unaware of the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Deputy for research, Shahid Beheshti Ave, Qazvin, Iran.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.QUMS.REC.1397.054
Health conditions studied
1
Description of health condition studied
coronary artery bypass graft (CABG) surgery
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Biomarkers( Erythrocyte Sediman Rate, C-Reactive Protein, Troponin I & CPK-MB)
Timepoint
On six hours after entering the ICU and the second & third day after surgery
Method of measurement
Laboratory kits
Secondary outcomes
1
Description
Arrhythmia
Timepoint
Length of Stay for Critical Care Admissions
Method of measurement
Patient file
2
Description
Length of Stay for Critical Care Admissions
Timepoint
Total number of days the ICU
Method of measurement
Patient file
3
Description
The number of days spent in hospital after breast cancer surgery
Timepoint
Discharge day from hospital
Method of measurement
Patient file
Intervention groups
1
Description
Intervention group: In the melatonin group: We will prescribe 3 milligram melatonin on the night before and the morning of surgery and after surgery, 3 milligram melatonin before of night's sleep for three days.
Category
Treatment - Drugs
2
Description
Control group: Placebo will be prescribed on the night before and the morning of surgery and after surgery, before of night's sleep for three days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
BuAli Sina Hospital
Full name of responsible person
Nahid Nasseh
Street address
BuAli Sina Hospital., BuAli Ave., Qazvin town
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 2930
Fax
+98 28 3332 6033
Email
boali.hospital@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Dept. of research., Shahid Beheshti, Ave., Qazvin., IRAN
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Fax
+98 28 3335 0056
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Saeedeh Shiravandi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Blvd, Qazvin, Iran.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 7006
Email
saeedeh.shrv@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nahid Nasseh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Blvd, Qazvin, Iran.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 7006
Email
Nahid.nasseh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nahid Nasseh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 7006
Email
nahid.nasseh@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
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