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.: PACTR201707002408136 Date of Approval: 06/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Passive leg raising predicting fluid responsiveness in pediatric intensive care unit
Official scientific title The role of passive leg raising in the predication of intravenous fluid responsiveness in pediatric intensive care unit patients
Brief summary describing the background and objectives of the trial Worldwide, more than 15 million patients are admitted to Intensive Care Units (ICUs) annually. In these patients, evaluation of the hemodynamic status is of upmost importance, since circulatory insufficiency is very commonly encountered in the ICU patients In order to identify patients who may benefit from fluid resuscitation which increases cardiac output, predictors of volume responsiveness are needed at the bedside. Passive leg raising (PLR) is one of the maneuvers that can increase the preload rapidly by autotransfusion of the blood originated from the veins of the lower extremities. This preload increase cardiac output in the patients who respond to fluid administration. The aim of the present work is to predict the ability of the heart to respond to any type of fluid resuscitation by using simple maneuver as passive leg raising and a special bedside non invasive tool ¿ICON" that measures cardiac index and stroke volume to optimize fluid administration in pediatric intensive care units.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Paediatrics,Pediatric intensive care unit patients
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/05/2015
Actual trial start date 01/05/2015
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 31/08/2017
Anticipated target sample size (number of participants) 57
Actual target sample size (number of participants) 57
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
Randomised Permuted block randomization (variable block size) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Echo group 3 times first baseline measurement second passive leg raising Third fluid bolus 30
Experimental Group Icon group 3 times first baseline measurement second passive leg raising Third fluid bolus 27
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
admission to PICU - Patients in shock that required immediate resuscitation. - Contraindications to leg elevation eg: deep venous thrombosis, lower extremities fractures and spine fractures. - Contraindications to fluid bolusing eg: acute kidney injury, heart failure, pulmonary edema and increased intracranial pressure. 1 Month(s) 12 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 25/05/2016 IRB, Ethics Committee, Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
Sultan Hussein Street, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stroke volume. On admission measurement (baseline)then after passive leg raising, then after fluid bolus
Primary Outcome Survival of patients Till end of follow up
Secondary Outcome Length of PICU stay. Till death or discharge from PICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Department, El Shatby hospital, Alexandria university Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ahmed El nawawy Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
Hadir Mohamed Hassouna Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
Passant Mohamed Farghaly 35 Mahmoud Sadki Street Sidi Beshr Alexandria 21611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Nawawy dr_anawawy@yahoo.com 002-034831061 Port Said St., ElShatby, Beside Bibliotheca of Alexandria
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics, Faculty of Medicine, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 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 00201003568008 Port Said St., ElShatby, Beside Bibliotheca of Alexandria
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecturer In Pediatrics
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information