Plain English Summary
Background and study aim
Coronary artery bypass grafting (CABG) surgery is one of the most common cardiac surgeries worldwide. Patients undergoing surgery because of the possibility of advanced atherosclerosis, mild systemic inflammation, and other comorbidities are always classified in high-risk groups. For this reason, predictive markers are essential for risk assessment. The Absolute Neutrophil to Lymphocyte Ratio (NLR) and Absolute Platelet to Lymphocyte Ratio (PLR) have been a topic of great interest in recent years in the field of heart disease and its low cost and availability properly noted.
L-carnitine is mainly made in the liver and kidney. L-carnitine is a key component of the transport of activated fatty acids through the mitochondrial membrane and has been shown in recent studies to have antioxidant and anti-inflammatory effects. It is mainly (approximately 98%) found in muscle tissue. The amount in the heart muscle is more than three times that of the striated muscle. In some heart diseases, L-carnitine deficiency has been observed. Studies have also evaluated the efficacy of L-carnitine supplementation orally or intravenously before, during, and after CABG.
In this study, we will investigate the effect of pre-operative L-carnitine supplementation on Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR).
Who can participate?
Adults undergoing elective CABG
What does the study involve?
Participants are randomly allocated to one of three groups.
Those in the first group receive 2gr L-carnitine 12 hours before surgery.
The second group will receive 5gr L-carnitine 12 hours before surgery.
The third group will receive a placebo.
All groups will have standard CABG surgery.
What are the possible benefits and risks of participating?
Those in the L-carnitine group might benefit from its anti-inflammatory effect.
Where is the study run from?
Cardiovascular research center, Shahid Beheshti University of Medical Sciences, Shahid Modarres Hospital, Tehran, (Iran)
When is the study starting and how long is it expected to run for?
November 2019 to March 2020
Who is funding the study?
Deputy of Research of Shahid Beheshti School of Medicine
Who is the main contact?
Dr. Amir Ebadinejad
amirebadinejad@sbmu.ac.ir
Trial website
Contact information
Type
Scientific
Primary contact
Dr Amir Ebadinejad
ORCID ID
https://orcid.org/0000-0002-3147-6103
Contact details
Cardiovascular research center
Shahid Modarres Hospital
Saadat Abad Boulevard
District 2
Tehran
Tehran
1998734383
Iran
+98 9351481771
amirebadinejad@sbmu.ac.ir
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IR.SBMU.RETECH.REC.1397.432
Study information
Scientific title
The effect of L-carnitine on neutrophil-lymphocyte ratio and platelet-lymphocytes ratio in patients undergoing coronary artery bypass grafting
Acronym
Study hypothesis
Regarding L-carnitine effect as an anti-inflammatory agent, administration of this supplement before coronary artery bypass grafting (CABG) can impact neutrophil-lymphocyte ratio and platelet-lymphocytes ratio
Ethics approval
Approved 04/10/2018, Ethics committee of Shahid Beheshti Medical University (Arabi Ave., Tehran, 193954719, Iran; +9822439951; mpd@sbmu.ac.ir ), ref: IR.SBMU.RETECH.REC.1397.60
Study design
Interventional single-center randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiac surgery
Intervention
Participants undergoing CABG are divided into three groups which receive a dose of supplement/placebo 12 hours before surgery:
1. Administration of 2 gr l-carnitine
2. Administration of 5 gr l-carnitine
3. Administration of placebo
Complete blood count (CBC) differential blood tests will be performed to analyse neutrophil-lymphocyte ratio and platelet-lymphocytes ratio before the surgery and each of 3 postoperative days.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Measured by CBC differential blood test pre-operatively and daily for three days post-surgery:
1. Neutrophil-Lymphocyte ratio
2. Platelet-Lymphocytes ratio
Secondary outcome measures
Pre-operatively and daily for three days post-surgery:
1. Echocardiographic indexes measured using ECG
2. The changes of mean platelet volume measured by CBC differential blood test
3. The changes of red cell distribution width measured by CBC differential blood test
Overall trial start date
23/11/2019
Overall trial end date
19/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients undergoing elective on-pump CABG for the first time
2. Adult aged 18 - 80 years
3. No history of NSAIDs and or corticosteroids use for four weeks before the operation
4. No history of inflammatory disorder for six months before the operation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Renal failure or creatinine level >1.5 mg/d
2. Hepatic failure
3. Inability to swallow oral medications
4. Contraindication to L-carnitine therapy
5. Emergent CABG
6. Use of L-carnitine within 4 weeks before the start of the study
7. Major surgery less than 28 days before the start of treatment
8. Recent history of any cancer
9. Prior radiotherapy or chemotherapy less than 4 weeks prior
10. Moderate to severe left ventricular dysfunction (EF<40)
11. Re-operation
Recruitment start date
07/12/2019
Recruitment end date
20/02/2020
Locations
Countries of recruitment
Iran
Trial participating centre
Shahid Modarres Hospital
Saadat Abad
Tehran
+98 1998734383
Iran
Sponsor information
Organisation
Shahid Beheshti University of Medical Sciences
Sponsor details
Deputy of Research of School of Medicine
7th Floor
Bldg No.2
Shahid Beheshti University of Medical Sciences
Arabi Ave
Velenjak
Tehran
1985717443
Iran
+98 2123871
info@sbmu.ac.ir
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
19/03/2021
Participant level data
Available on request
Basic results (scientific)
Publication list