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.: PACTR201801002954243 Date of Approval: 09/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Can Bedside Measurements Of Inferior Vena Cava Improve Pediatric Septic Shock Management?
Official scientific title Bedside Measurements Of Inferior Vena Cava In Evaluation And Resuscitation Of Pediatric Septic Shock
Brief summary describing the background and objectives of the trial Current paediatric fluid resuscitation guidelines are based on the concept of empiric fluid loading using vital signs as a marker of response to treatment. During treatment, physical examination may not be sensitive enough to detect early and subtle changes in pathophysiology which can have important implications for treatment and outcomes. Central venous pressure has long been used to guide fluid management; however, data suggest that in critically ill patients, central venous pressure may not correlate with the effective intravascular volume. Point-of-care ultrasound has been increasingly used in evaluating septic shocked patients including the measurement of inferior vena cava (IVC) diameter and collapsibility. A dynamic evaluation of IVC respiropasic variation may correlate better with the intravascular volume than a single static measurement of the vessel size.12 The present study primary aim was the evaluation of echocardiography role in optimizing fluid management in pediatric septic shock through monitoring the IVC respirophasic variation and diameter.
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 Supportive care
Anticipated trial start date 01/10/2017
Actual trial start date 01/10/2017
Anticipated date of last follow up 28/02/2018
Actual Last follow-up date 28/02/2018
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 100
Recruitment status Closed to recruitment,follow-up continuing
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 (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 Echocardiography group Echo. at time of admission, 5, 10, 15, 20-30 minutes, 1, 6 hours, from admission and daily thereafter till patient was discharged or deceased. 50
Control Group Control Standard therapy according to international Pediatric Sepsis Consensus 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consecutive patients having a new episode of septic shock on admission to the PICU. Pediatric septic shock is defined based on the American College of Critical Care Medicine and International Pediatric Sepsis Consensus. Patients with increased intrabdominal pressure such as organomegaly or peritoneal dialysis, cardiothoracic surgery including chest tube insertion and congenital heart disease will be excluded 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 18/10/2017 IRB: The ethics committee of the faculty of medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, E Messalah Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome IVC collapsability as a predictor of volume status (%) 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.
Primary Outcome Resuscitation time (hours) till resuscitation
Secondary Outcome Shock reversal time (hours) From admission till shock reversal (in hours)
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 Portsaid 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 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
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 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Hadir Hassouna hadirelrouby@yahoo.com 002-01003568008 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Lecturer in 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