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.: PACTR202405722801578 Date of Approval: 02/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the first fluid bolus with or without inotropes/vasopressors on cardiac index in children with septic shock
Official scientific title Evaluation of the first fluid bolus with or without inotropes/vasopressors on cardiac index in children with septic shock
Brief summary describing the background and objectives of the trial Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is a leading cause of morbidity, mortality, and healthcare utilization for children worldwide. Globally, an estimated 22 cases of childhood sepsis per 100,000 person-years and 2202 cases of neonatal sepsis per 100,000 live births occur, translating into 1.2 million cases of childhood sepsis per year. More than 4% of all hospitalized patients less than 18 years and~8% of patients admitted to PICUs in high-income countries have sepsis.( Fluid resuscitation alone is frequently insufficient to restore a minimal organ perfusion pressure in septic shock. Fluid-refractory septic shock is defined as persistent shock despite at least 40–60 ml/kg of fluid resuscitation in the first hour. In these cases, inotropic or vasopressor therapy should be initiated, ideally within the first 60 minutes of resuscitation. This study is designed to evaluate cardiac index after fluid bolus only versus fluid bolus plus inotropes/vasopressors at the end of first bolus in children with severe sepsis/septic shock in the pediatric intensive care unit (PICU) of Alexandria University.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2022
Actual trial start date 01/05/2023
Anticipated date of last follow up 31/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status 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 After The First Fluid Bolus Dobutamine 5-20 mic/kg/min Milrinone 0.25-0.75mic/kg/min Epinephrine 0.02-1.2 mic/kg/min Noreadrenaline 0.2-1.2 mic/kg/min after resuscitation till shock reversal Introduction of inotropes or vasopressors after first fluid bolus of 10-20 ml/kg Saline or Ringer to minimize the risk of fluid overload 24
Control Group After The Second Fluid Bolus Dobutamine 5-20mic/kg/min Milrinone 0.25-0.75mic/kg/min Epinephrine 0.02-1.2 mic/kg/min Noreadrenaline 0.2-1.2 mic/kg/min after resuscitation till shock reversal Introduction of inotropes or vasopressors after second fluid bolus of 10-20 ml/kg Saline or Ringer to minimize the risk of fluid overload 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with severe sepsis/septic shock as defined by The Surviving Sepsis Campaign (SSC) guidelines 2020. - Congenital / acquired cardiac disease. - Oncological patients on chemotherapy. - Chronic hemolytic anemia with cardiac affection. - Chronic respiratory disease. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),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 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 Cardiac index after 5 minutes and 1 hour of itnervention
Primary Outcome Resuscitation time Time until resuscitation
Secondary Outcome Death Until discharged from Pediatric Intensive Care Unit
Secondary Outcome Reversal of shock Until Shock Reversal
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
Alaa Amgad Mohamed Samir Wasel Elmadrees street kom hamada elbeharia Kom Hamada 22821 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 Alexandri a 21563 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ahmed El nawawy Portsaid street, El Shatby Alexandria 21563 Egypt
Azza Ahmad Moustafa Portsaid street, El Shatby Alexandria 21563 Egypt
Hadir Mohamed Hassouna Portsaid street, El Shatby Alexandria 21563 Egypt
Alaa Amgad Mohamed Samir Wasel Elmadrees street kom hamada elbeharia kom Hamada 22821 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 00201003568008 Portsaid street, El-shatbi
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Lecturer of Pediatrics Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Alaa Wasel Alaawasel94@gmail.com 00201014951516 Portsaid street, El-shatbi
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Pediatric resident at Alexandria Children Hospital of Alexandria university
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