Condition category
Circulatory System
Date applied
06/11/2019
Date assigned
26/11/2019
Last edited
26/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

26/11/2019: Trial’s existence confirmed by Ethics committee of Shahid Beheshti Medical University