The goal of this randomized clinical trial is to evaluate the impact of L-carnitine on the prevention of postoperative increase in inflammatory biomarkers following coronary artery bypass grafting (CABG) surgery. All patients who are a candidate for CABG without a prior history of seizure, thyroid dysfunction, liver or kidney failure and L-carnitine hypersensitivity included in our study. 100 patients were randomly assigned into two groups of 50 people (intervention and control groups). Permuted random block method will be used for randomization. The first group of patients will receive 6 g L-carnitine (2 g every 8 hours) for 2 days before and after surgery. The next group will not receive the drug. This is a single blinded clinical trial as the investigator is not aware of the arms. In both groups, blood samples are collected and biomarkers of inflammation including NLR, PLR and hs-CRP (48 hours before and after surgery) will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706108698N20
Registration date:2017-07-11, 1396/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-11, 1396/04/20
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Potential effect of L-Carnitine on inflmmatory biomarkers post cardiac artery bypass graft surgery
Public title
The Effect of L-Carnitine on Inflammaton Post Cardiac Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The patients who are a candidate for Coronary artery bypass graft surgery in Tehran Heart Center; Exclusion criteria: Valvular surgery; History of seizure; History of hypersensitivity reaction to l-carnitine; Chronic liver failure (Liver enzymes more than 3 times of upper limit of normal); Chronic kidney disease (Stage IV and V); Hypothyroidism
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tehran University of Medical Sciences
Street address
Keshavarz Blv., Qods and Keshavarz Intersection
City
Tehran
Postal code
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2361
Health conditions studied
1
Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I20
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
NLR
Timepoint
Before and 48 hours post surgery
Method of measurement
CBC
2
Description
PLR
Timepoint
Before and 48 hours post surgery
Method of measurement
CBC
3
Description
hs-CRP
Timepoint
Before and 48 hours post surgery
Method of measurement
Elisa kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: L-carnitine 3 g every 8 hours from 2 days before to 2 days after surgery
Category
Treatment - Drugs
2
Description
Intervention 2: No additional drug would be prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Azita Hajhossein Talasaz
Street address
North Kargar and Jalale Ale Ahmad Intersection
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
6th Floor, Keshavarz Blv. and Qods St. Intersetion
City
Tehran
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, Tehran 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
Tehran University Of Medical Science
Full name of responsible person
Azita Hajhossein Talasaz
Position
Associate Professor
Other areas of specialty/work
Street address
16th Azar St., School of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8802 9242
Fax
Email
a-talasaz@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Mojtahedzadeh
Position
Professor
Other areas of specialty/work
Street address
16th Azar St., School of Pharmacy
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
mojtahed@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Associate Professor
Other areas of specialty/work
Street address
16th Azar St., School Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8802 9242
Fax
Email
a-talasaz@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)