Effect of L-Carnitin on IL6 and HS– CRP levels after Coronary Artery Bypass Graft Surgery
Design
Clinical trials with community based and pragmatic control group, with parallel groups ,randomized
Settings and conduct
The present study will be designed as a randomized clinical trial. All patients with inclusion criteria will be enrolled in the study after completing a written explanation and obtaining written consent and will enter the treatment groups using a random number table.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18-70 years؛ Complete the consent form
Not receiving non-steroid anti-inflammatory drugs for at least 2 weeks before surgery ;
Not receiving corticosteroid;
Exclusion criteria:
Drinking alcohol and drugs;
History of seizure or epilepsy;
Patients with a history of cevebrovascular diseases ;
Chronic liver failure (enzymes higher than 2 times normal);
Chronic renal failure (STAGE 4 & 5);
Coronary artery bypass surgery without using a bypass pump;
Emergency surgery;
CABG surgery with other simultaneous actions;
EF<40%
Intervention groups
The first treatment group (20 people), with standard interactions and treatments, receive 1 g l-carnitine per liter of Cardioplegia solution.
The second group treatment (20 people) received standard 3-grams of L-carnitine per liter of Cardioplegia solution.
Patients in the control group (20 people) also receive normal saline in addition to standard treatment (this group does not receive any treatment other than standard treatment).
Main outcome variables
IL6 and HS– CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150725023332N1
Registration date:2019-09-23, 1398/07/01
Registration timing:retrospective
Last update:2019-09-23, 1398/07/01
Update count:0
Registration date
2019-09-23, 1398/07/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2283 1058
Email address
alirezajahangiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-Carnitin on IL6 and HS– CRP levels after Coronary Artery Bypass Graft Surgery
Public title
Effect of L-Carnitin on Coronary Artery Bypass Graft Surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild-to-moderate heart failure (EF = 55-40%) for coronary artery bypass graft surgery (elective CABG)
Exclusion criteria:
History of seizure or epilepsy
Patients with a history of cevebrovascular diseases
Chronic liver failure (enzymes higher than 2 times normal)
Chronic renal failure (STAGE 4 & 5)
Drinking alcohol and drugs
Coronary artery bypass surgery without using a bypass pump
CABG surgery
EF<40%
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial, the randomization process was performed simply (By creating tables of numbers and coding patients based on numbers in the table) .The subjects were randomly divided into three separate blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Shahid Beheshti University
Street address
Next to Ayatollah Taleghani Hospital ,Evin , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Approval date
2018-04-15, 1397/01/26
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.432
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft Surgery
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
Primary outcomes
1
Description
Serum HS-CRP and IL-6 levels in three groups of patients
Timepoint
At baseline and 24 hours after surgery
Method of measurement
Blood sampling, blood serum isolation, and finally biochemical tests
Secondary outcomes
1
Description
Measurement of serum levels of CPK-MB and Troponin in patients undergoing surgery
Timepoint
It will be measured at baseline 8 and 24 hours after surgery
Method of measurement
Blood sampling, blood serum isolation, and finally biochemical tests
Intervention groups
1
Description
Intervention group: Patients in the first group (20 patients) with standard interactions and treatments receive 1 g l-carnitine per liter of Cardioplegia solution.
Category
Treatment - Surgery
2
Description
Intervention group: The second group therapy (20 people), in addition to standard treatments, receives 3 g of l-carnitine per liter of Cardioplegia solution.
Category
Treatment - Surgery
3
Description
Control group: For patients in the control group (20 people), they receive normal saline in addition to standard treatment (this group does not receive any treatment except standard treatment).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Alireza Jahangirifard
Street address
Darabad - The Hospital of Messiah Daneshvari
City
Tehran
Province
Tehran
Postal code
19556
Phone
+98 21 2712 3000
Fax
+98 21 2610 9484
Email
Alirezajahangiri@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin zarghi
Street address
Taleghani Hospital, Shahid Beheshti University of Medical Sciences and Health Services
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza jahangirifard
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Darabad - The Hospital of Messiah Daneshvari
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2537
Fax
+98 21 2610 9644
Email
Alirezajahangiri@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Jahanngirifard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Darabad - The Hospital of Messiah Daneshvari
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2537
Fax
+98 21 2610 9644
Email
Alirezajahangiri@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Khalili
Position
Specialist (non-faculty)
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Darabad - The Hospital of Messiah Daneshvari
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2537
Fax
+98 21 2610 9644
Email
alikhalili701@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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available