The goal of this randomized clinical trial is evaluation of the impacts of L-carnitine on the prevention of postoperative atrial fibrillation following coronery artery bypass grafting (CABG) surgery. One of the most common adverse effects after CABG surgery is atrial fibrillation (AF) which occurs to 15% to 40% of the patients. AF causes pump failure and ventricular filling dysfunction, so prevention of AF has a great effect on reducing the mortality of patients. L-carnitine has the ability to transport the long-chain fatty acids from cytoplasm to mitochondria where the oxidative metabolism produces ATP for myocardia. One hundred patients were randomly placed in two groups of 50 people (intervention and control group). The first group of patients will receive 3 g L - carnitine (1 g every 8 hours) for 2 days before and after surgery. The next group will not receive the drug. In both groups, blood samples are collected and CK-MB and Troponin T (as baseline level before surgery and 8 and 24 hours after surgery) will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404268698N13
Registration date:2014-06-12, 1393/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-12, 1393/03/22
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
2013-08-01, 1392/05/10
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of L-carnitine on CK-MB and troponin T value following coronery artery bypass grafting (CABG) surgery
Public title
Evaluating the effect of L-carnitine on CK-MB and troponin T value following coronery artery bypass grafting (CABG) surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The patients who candidate for Coronary artery bypass graft surgery in Tehran Heart center are selected by simple randomised method; There are not any limitations for age; and sex in this study. Exclusion criteria: Valvular surgery; History of supraventricular arrhythmia; History of siezure; History of hypersensitivity reaction to l-carnitine; Chronic liver failure (Liver enzymes more than 3 times of ULN); Chronic kidney disease (Stage IV & V); Hypothyroidism; Use of Magnesium, NSAIDs and Antiarrhythmic medication, history of myocardial infarction within 1 month of hospitalization
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center
Street address
Jalal Ale Ahmad, North Karegar
City
Tehran
Postal code
Approval date
2012-08-13, 1391/05/23
Ethics committee reference number
567
Health conditions studied
1
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Atrial fibrillation
Timepoint
5 days post CABG surgery
Method of measurement
ECG, CK-MB
Secondary outcomes
1
Description
Atrial fibrillation
Timepoint
5 days post CABG surgery
Method of measurement
Troponin T
Intervention groups
1
Description
Intervention group: administration of L-carnitine, 1 g oral solution vial, 3 times a day (TDS) every 8 hours, duration of intervention is 4 days (from 48 hours before surgery until 48 hours after it)
Category
Treatment - Drugs
2
Description
Control group: This group does not receive any interventions
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Fatemeh Saeidi
Street address
Keshaverz Blv, Qods St, Tehran university of medical sciences, Research deputy
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Sciences
Full name of responsible person
Azita Hajhossein Talasaz
Position
Assisstant professor, Clinical pharmacy specialist
Other areas of specialty/work
Street address
Enghelab St., 16 Azar St., Faculty of pharmacy, Tehran university of medical sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
atalasaz@razi.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
Azita Hajhossein Talasaz
Position
Assisstant professor, Clinical pharmacy specialist
Other areas of specialty/work
Street address
Enghelab St., 16 Azar St., Faculty of pharmacy, Tehran university of medical sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
atalasaz@razi.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
Assisstant professor Clinical pharmacy specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
atalasaz@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)