Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202010570607420 Date of Registration: 29/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of L-carnitine on myocardial injury in children undergoing open heart surgery
Official scientific title Effect of L-carnitine on myocardial injury in children undergoing open heart surgery
Brief summary describing the background and objectives of the trial Myocardial injury and myocardial dysfunction after cardiac surgery of congenital heart disease are closely related to morbidity and mortality. Cardiopulmonary bypass (CPB) is related to multiple effects that may contribute to postoperative myocardial injury and cardiac dysfunction including ischemia-reperfusion injury after removal of aortic clamp, the subsequent generation of reactive oxygen species and increased production of inflammatory mediators. Oxidative stress may promote myocardial injury either due to direct myocardial damage through lipid peroxidation and protein changes or through induction of apoptosis of cardiomyocytes that are exposed to ischemia-reperfusion . There are two apoptotic pathways; the extrinsic pathway which activated by death receptors and the intrinsic pathway which can be activated by hypoxia and oxidative stress that occur due to cardiopulmonary bypass. L-carnitine is an endogenous amino acid that has an important role in metabolism of fatty acid and carbohydrate. It was reported to have myocardial protective effects in rheumatic valvular surgery and coronary artery bypass graft (CABG) in adults. Aim of the work: The aim of this study is to investigate the possible myocardial protective effect of L-carnitine in children undergoing open heart surgery by investigating L-carnitine effects on oxidative stress, apoptosis and myocardial injury induced by cardiopulmonary bypass.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/07/2020
Actual trial start date 01/11/2020
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lcarnitine 50mg/kg/day once for 10 days before surgery children receive oral L-carnitine 50mg/kg/day once daily for 10 days before cardiac surgery then Blood samples were taken at baseline 1 h before surgery for all participants and 12 h after surgery both groups to measure several biochemical measurements such as malodialdehyde, caspase-3, troponin I, and CK-MB. 30
Control Group placebo glucose 5% in dropper 10 days before surgery children receive oral placebo in the form of glucose 5% once daily for 10 days before cardiac surgery then Blood samples were taken at baseline 1 h before surgery for all participants and 12 h after surgery both groups to measure several biochemical measurements such as malodialdehyde, caspase-3, trponin I, and CK-MB. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children undergoing cardiac surgery for correction of congenital heart disease children with infective endocarditis, children with heart failure, children with metabolic disease, children with renal or hepatic disease. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Month(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/03/2020 Local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
Elgiesh street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of L-carnitine on troponin I levels 1 h before and 12 h after cardiac surgery
Secondary Outcome effect of L-carnitine on CK-MB, caspase-3, malodialdehyde 1 h before and 12 h after cardiac surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University hospital elgheish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Doaa El Amrousy Elmotasem street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine of tanta university elgeish street Tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Dalia ElAfify Motaekel street Tanta 32421 Egypt
Doaa El Amrousy Elmoatsem street tanta 32711 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com +201278155283 Elmotasem street
City Postal code Country Position/Affiliation
Tanta 32711 Egypt assistant professor of pediatrics
Role Name Email Phone Street address
Public Enquiries Mohamed Elkashlan mohamedkashlan@yahoo.com +20122337746 Elmotasem street
City Postal code Country Position/Affiliation
Tanta 32711 Egypt Assistant professor of anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Dalia El Afifi daliaelafify@yahoo.com +201223180650 elmotawakel sreet
City Postal code Country Position/Affiliation
Tanta 32421 Egypt lecturer of clinical pharmacy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study protocol and data will be available on request Statistical Analysis Plan,Study Protocol after completion of research and publication of the paper on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information