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.: PACTR201702002016420 Date of Approval: 02/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intraosseous versus Intravenous Access in Pediartc Septic Shock Patients Admitted to Alexandria University Pediatric Intensive Care Unit
Official scientific title Intraosseous versus Intravenous Access in Pediartc Septic Shock Patients Admitted to Alexandria University Pediatric Intensive Care Unit
Brief summary describing the background and objectives of the trial Severe sepsis and septic shock are major healthcare problems. The corner stone of emergency management of sepsis is early, goal-directed therapy, The American heart association ( AHA) stated in its 2010 guidelines that IO access is a rapid, safe, effective, and acceptable route for vascular access in children, and it is useful as the initial vascular access in cases of cardiac arrest and it was not reviewed in 2015 but it didn¿t include its use in septic shock.The aim of this work was to evaluate the effect of initial intraosseous access versus initial intravasvenous access on resuscitation of paediatric patients with septic shock admitted to intensive care unit
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Pediatric Septic Shock
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2013
Actual trial start date 01/01/2013
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date 31/12/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous vascular access (IV) peripheral cannulation 30
Experimental Group intraosseous vascular access (IO) using EZ-IO needles 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A new episode of septic shock on admission to the PICU. - cellulitis, - osteomyelitis , - fractured bone in the lower limbs - severe osteoporosis - osteogenesis imperfecta 1 Month(s) 36 Month(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 15/01/2013 Faculty of Medicine, Alexandria University IRB
Ethics Committee Address
Street address City Postal code Country
Chambillion st. Azarita, Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Return of spontaneous circulation (capillary refill time) measured from the time of picking the equipment of the IV or IO access device (peripheral cannulation or IO device) until the successful first administration of saline
Secondary Outcome PICU length of stay till time of discharged or death
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric intensive care unit, El Shatby hospital, Alexandria university Port Said street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric department, Faculty of Medicine, Alexandria University Port Said street, El Shatby Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric department, Faculty of Medicine, Alexandria University Port Said street, El Shatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmad Ahmad El Nawawy Port Said street, El Shatby Alexandria 21526 Egypt
Omneya Magdy Omar Port Said street, El Shatby Alexandria 21526 Egypt
Mona Khalil Mohammed Port Said street, El Shatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad El Nawawy dr_anawawy@yahoo.com 002034831061 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Professor of Pediatrics, Faculty of Medicine, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Omneya Omar drmonymagdy@yahoo.com 00201223768859 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Lecturer of Pediatrics, Faculty of Medicine, University of Alexandria
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information