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.: PACTR202302533541102 Date of Approval: 01/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Study Of Optimum Duration Of Administration Of First Fluid Bolus in Pediatric Septic Shock: A Randomized Controlled Trial
Official scientific title A Study Of Optimum Duration Of Administration Of First Fluid Bolus in Pediatric Septic Shock: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Sepsis is a leading cause of morbidity, mortality, and healthcare utilization for children worldwide. The majority of children who die of sepsis suffer from refractory shock and/or multiple organ dysfunction syndrome (MODS), with many deaths occurring within the initial 48 to 72 hours of treatment. So, early identification and appropriate resuscitation and management are therefore critical to optimize outcomes for children with sepsis. Current guidelines for septic shock in children advocate aggressive fluid resuscitation of up to 60 mL/kg boluses of 20 mL/kg each over 5–10 minutes to achieve the desired heart rate and blood pressure. The boluses are repeated until perfusion improves, unless hepatomegaly, increased work of breathing, rales, or a gallop rhythm develops. The goal of such early and rapid fluid resuscitation according to Early Goal Directed Therapy (EGDT) to obtain distinct resuscitation goals [i.e., central venous pressure (CVP) =8–12 mmHg; mean arterial pressure (MAP) =65–90 mmHg; urinary output >0.5 mL/kg/hour; central venous oxygen saturation (ScvO2) >70% within the first six hours]. Studies have shown that this aggressive approach to fluid resuscitation leads to a nine-fold reduction in mortality. Researchers have begun questioning the basics of fluid resuscitation including the need for and duration of administration of boluses. In the Fluid Expansion as Supportive Therapy [FEAST trial]. The only randomized controlled trial (RCT) published showed increased rates of hepatomegaly but not ventilation with boluses administered so quickly. Thus, there is paucity of evidence on the optimal duration of administration of fluid boluses in the first hour of fluid resuscitation. Given the background, this study is designed to address the question as to what the optimal duration/speed of first bolus fluid administration during initial resuscitation would be safe and better tolerated in children with septic shock in the initial hour of resuscitation. The aim
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Pediatric Septic Shock
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2023
Actual trial start date
Anticipated date of last follow up 31/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 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 Ten minutes 20 ml/kg of normal saline Once on admission Patients will receive the first fluid bolus of 20ml/kg over 10 min. by infusion pump. 20
Control Group Twenty minutes 20 ml/kg of normal saline Once on admission Patients will receive the first fluid bolus of 20ml/kg over 20 min. by infusion pump. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Severe sepsis (definition is according to the international pediatric sepsis consensus conference). • Septic shock (defined as severe infection leading to cardiovascular dysfunction (including hypotension, need for treatment with a vasoactive medication, or impaired perfusion). Any associated chronic illness as • Congenital heart disease. • Severe respiratory disease with failure to achieve threshold arterial oxygen saturation 92%. • Chronic renal disease. Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 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 20/10/2022 Ethics Committe of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Messalah Alexandria Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiac index On admission and at 6 hours after admission
Primary Outcome Stroke volume index On admission and at 6 hours after admission
Secondary Outcome Mechanical ventilation Within the first 6 hours after admission
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Intensive Care Unit Alexandria University Children hospital Port saeed street El-Shatby Alexandria 21321 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliaa Tarek Mohamed Salem 42 ElFaateh Street Tanta 31516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Department Alexandria University Port saeed street, El-Shatby Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Azza Ahmed Ahmed Moustafa Port saeed street ElShatby Alexandria 21521 Egypt
Ahmed Ahmed Sayed ElNawawy Port saeed street ElShatby Alexandria 21521 Egypt
Aliaa Tarek Mohamed Salem 42 ElFaateh Street Tanta 31516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed ElNawawy Dr_anawawy@yahoo.com +2034837454 Port saeed street ElShatby
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor Pediatrics Faculty of Medicine Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Azza Moustafa profdrazzamoustafa@alexmed.edu.eg +201008948826 Port saeed street ElShatby
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor Pediatrics Faculty of Medicine Alexandria University Egypt
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
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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