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.: PACTR201907742119058 Date of Approval: 22/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of citicoline as neuroprotector in post cardiac arrest in PICU; A Randomized Controlled Trial
Official scientific title Efficacy of citicoline as neuroprotector in post cardiac arrest in PICU; A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Survival after cardiac arrest has been defined as being neurologically normal at hospital discharge or at a specified time after discharge for humans, or neurologically intact survival at 24 or 48 hours for experimental animals. When definitions of survival such as neurologically normal or near normal are used, it is clear that survival rates for cardiac arrest with cardiopulmonary resuscitation have been very low and, with the exceptions of early application of an AED (automated external defibrillator), have remained stagnant over the last few decades. Citicoline is an essential intermediate in the synthesis of cell membrane phospholipids and its formation is the rate-limiting step in phosphatidylcholine synthesis. It plays several important roles in human physiology, including enhancement of structural integrity and signaling for cell membranes, support of acetylcholine synthesis, and synthesis of betaine, a methyl donor. Citicoline provides the brain with a source of choline and cytidine, which are efficiently used in the Kennedy cycle to generate phospholipids. It is able to attenuate the production of free radicals in ischemic conditions, while it also stimulates glutathione synthesis and the activity of glutathione reductase. Citicoline might be promising in the treatment of patients with various forms of neurologic injury.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2019
Actual trial start date
Anticipated date of last follow up 01/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
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 Citicoline 10mg/kg/12hr 6 weeks The group involved 30 children will receive citicoline 10mg/kg/12hr for 6 weeks plus other supportive measures in PICU. Glasgow Coma Score, seizures frequency, type and duration, duration of PICU stay, pupillary light, corneal reflexes and modified Rankin scale for children will be done before and after the end of the treatment. 30
Control Group placebo twice per day 6 weeks The group involved 30 children will receive placebo plus usual supportive measures in PICU after cardiac arrest. All patients will be evaluated for Glasgow Coma Score, seizures frequency, type and duration, duration of PICU stay, pupillary light, corneal reflexes and modified Rankin scale for children before and 6 weeks after placebo treatment. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children post cardiac arrest (regardless the cause) who are successfully resuscitated with return of spontaneous circulation and who are unconscious with Glasgow coma scale (GCS) below 7 Post cardiac arrest patients who received any neuroprotective maneuver or drugs like hypothermia Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,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 01/04/2019 local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
elgeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome glascow coma score before treatment , weekly and 6 weeks after treatment
Secondary Outcome frequency, type and duration of seizures, duration of PICU stay, pupillary light and corneal reflexes, side effects, mortality, and modified Rankin scale for children before treatment , weekly and 6 weeks after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta University hospital Elgeish street tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fund Elmotasem street Tanta 31511 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 University
COLLABORATORS
Name Street address City Postal code Country
Abeer Salama madina street Kafr Elsheikh 34512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com 00201278155283 Elmotasem street
City Postal code Country Position/Affiliation
Tanta 32711 Egypt assistant professor of pediatrics
Role Name Email Phone Street address
Public Enquiries Amr Zoair azoair@hotmail.com 00201001108683 Elnady street
City Postal code Country Position/Affiliation
Tanta 31512 El Salvador Professor of pediatrics and dean of Faculty of medicine Tanta University Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elkashlan mohamedkashlan@yahoo.com 00201222337746 Elmotasem street
City Postal code Country Position/Affiliation
Tanta 32711 Egypt consultant of anesthesiology
Role Name Email Phone Street address
Principal Investigator Abeer Salama abeersalamah@yahoo.com 00201145140988 Madina street
City Postal code Country Position/Affiliation
Kafr Elsheikh Egypt lecturer of pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data that underlie the results reported in this trial after deidentification Statistical Analysis Plan,Study Protocol within 12-24 months of beginning of the study controlled
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