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.: PACTR201609001786696 Date of Approval: 19/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of echocardiography in reduction of shock reversal time
Official scientific title Role Of Echocardiography In Reduction Of Shock Reversal Time In Septic Shock In Alexandria University Pediatric Intensive Care Unit
Brief summary describing the background and objectives of the trial The rationale of our study was to evaluate the use of transthoracic echocardiography in an attempt to reduce shock reversal time in pediatric septic shock by optimizing fluid, inotropes and vasoactive therapy based on its findings. Thus, providing useful data to be incorporated in future pediatric sepsis guidelines.
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 01/09/2013
Actual trial start date 01/09/2013
Anticipated date of last follow up 30/09/2015
Actual Last follow-up date 30/06/2016
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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 randomisation (block size was variable minimum of 4) 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 Echocardiography group Echo. at time of admission, 5minutes , 10minutes, 15minutes, 20minutes, 30minutes,1 hour,6 hours, 24hours from admission and daily thereafter till patient was discharged or deceased. 45
Control Group Control group Standard therapy according to international Pediatric Sepsis Consensus 45 Active-Treatment of Control Group
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. patients with primary conditions associated with myocardial ischemia or cell injury (eg, myocarditis, cardiomyopathy), cardiothoracic surgery, Kawasaki disease and congenital heart disease. 1 Month(s) 16 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 03/07/2013 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 Shock reversal time From admission till shock reversal (in hours)
Secondary Outcome Length of PICU stay, From admission to discharge or deceased
Secondary Outcome Fate From admission to discharge or deceased
Secondary Outcome 28 day mortality From admission to discharge or deceased
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric intensive care unit, El Shatby hospital,Alexandria university Portsaid street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric department, Faculty of Medicine, Alexandria University chambillion st. Azarita, Alexandria 21563 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric department, Faculty of Medicine, Alexandria University Portsaid street, El Shatby Alexandria 21563 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ahmed El nawawy Portsaid street, El Shatby Alexandria 21563 Egypt
Ali Abdel Mohsen Portsaid street, El Shatby Alexandria 21563 Egypt
Hadir Mohamed Hassouna Portsaid street, El Shatby Alexandria 21563 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed 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 21646 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Ali Abdel Mohsen aly_elmohsen@yahoo.com 00201222621981 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Assistant Professor of pediatrics, Faculty of Medicine, University of Alexandria
REPORTING
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Result URL Hyperlinks
Changes to trial information