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.: PACTR202402726337674 Date of Approval: 07/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the amount of blood transfusion required for optimum oxygen markers in hemodynamically unstable non-hemorrhagic pediatric shock
Official scientific title Evaluation of the amount of blood transfusion required for optimum oxygen markers in hemodynamically unstable non-hemorrhagic pediatric shock
Brief summary describing the background and objectives of the trial Pediatric sepsis remains an important public health issue, and has similar incidence, morbidity, and mortality rates compared with critically ill adult populations. Severe sepsis accounts for >8% of all critically ill children and causes more than 4.5 million childhood deaths worldwide annually. In the United States, about one-third of deaths result from severe sepsis in pediatric intensive care units. The majority of children suffering from sepsis die from refractory septic shock or multiple organ dysfunction syndrome. In Alexandria University Pediatric Intensive Care Unit (PICU) in 2016 it was estimated that 24% of patients suffer from severe sepsis. According to the consensus recommendations of The Pediatric Critical Care Transfusion and Anemia Expertise Initiative (TAXI), it cannot make a recommendation regarding transfusion thresholds for critically ill children with unstable non-hemorrhagic shock. To date, randomized trials of liberal versus restrictive RBC transfusion practice in the acute shock setting are lacking. The only RCT in critically ill children, the Transfusion Strategies for Patients in PICU (TRIPICU) study, excluded hemodynamically unstable children. That’s why our PICU research team in Alexandria University is interested to share in the answer to this issue in critically unstable cohort. The study is designed to assess when the risk/benefit of anemia correction (red blood cell transfusion) is better than risk/benefit of anemia tolerance in non-hemorrhagic unstable pediatric shock and to determine the risk/benefit ratio of different level of hemoglobin that will lead to success at reaching the six hours early goal directed therapy and optimum myocardial function.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/02/2024
Actual trial start date
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Continuous monitoring N/A Until reaching ScvO2 ≥70% Therapies will be directed toward the endpoint of ScvO2 ≥70% using continuous monitoring. If the ScvO2 is found < 70%, even with normalization of perfusion pressure, urine output and peripheral perfusion, packed red blood cells (if hemoglobin < 10 g/dl) will be administered until reaching ScvO2 ≥70%. 30
Control Group Venous blood analysis N/A Until hemoglobin is between 7-9 g/dl The ScvO2 will be measured by venous blood analysis (values will be recorded, but not used to guide treatment), packed red blood cell transfusion according to targeted transfusion equation to keep hemoglobin between 7-9 g/dl. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with severe sepsis or fluid refractory septic shock who are hemodynamically unstable. - Patients with uncorrected cyanotic heart disease. - Patients with chronic hemoglobinpathies or any hematological diseases . - Patients with decompensated chronic cardiac conditions - Patients with chronic lung disease - Patients referred to PICU more than 6 hours after the diagnosis of severe sepsis or septic shock Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Month(s) 15 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 Normalization of oxygen debt markers Continuous monitoring
Primary Outcome Successful resuscitation achievement of six hours early goal directed therapy (EGDT) Continuous monitoring
Secondary Outcome Length of stay in Pediatric Intensive Care Unit Althrough the study in PICU
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
Radwa Galal Abdelhamid Ghazal 273 porsaid street Cleopatra Alexandria 21618 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
Manal Abdel Malik Antonios Portsaid street, El Shatby Alexandria 21563 Egypt
Radwa Galal Abdelhamid Ghazal 273 porsaid street Cleopatra Alexandria 21618 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
Scientific Enquiries Manal Antonios malakmanal@yahoo.com 00201229733422 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
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