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.: PACTR201809660298842 Date of Approval: 03/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Systemic Oxygen Delivery Targeted Hemoglobin Level in Ventilated Septic Shock Children at Alexandria Intensive Care Unit
Official scientific title Systemic Oxygen Delivery Targeted Hemoglobin Level in Ventilated Septic Shock Children at Alexandria Intensive Care Unit
Brief summary describing the background and objectives of the trial In Transfusion Strategies for Patients in Pediatric Intensive Care Units study (TRIPICU) study of stable, critically ill children shows a hemoglobin threshold of 7 g per deciliter for red-cell transfusion can decrease transfusion requirements without increasing adverse outcomes. In TRIPICU children with stable sepsis, no evidence was found that a restrictive red cell transfusion strategy, as compared to a liberal one, increased the rate of new or progressive multiple organ dysfunction syndromes. Furthermore, a restrictive transfusion threshold significantly reduced exposure to blood products. Data suggest that a hemoglobin level of 7.0 g/dl may be safe for stabilized children with sepsis, but further studies are required to support this recommendation. According to surviving sepsis campaign, the optimal hemoglobin for a critically ill child with severe sepsis is not known. The rationale of the current study is to overcome the limitations of previous studies in same field by targeting normal systemic oxygen delivery not hemoglobin level per say in critically ill septic shock mechanically ventilated children to achieve resuscitation end points, microcirculatory parameters and decreasing mechanical ventilation days.
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 Mechanically ventilated septic shock children
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2018
Actual trial start date 01/10/2018
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date 31/10/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 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 Targeting optimization of systemic oxygen delivery 24 hour The cardiac output will be measured by echocardiography then target hemoglobin will be calculated according to the following equation to achieve the optimum systemic oxygen delivery (570-670 ml/ min/m2) according to cases' body surface area.: Systemic oxygen delivery (ml \ minute) = cardiac output (l\ minute) x arterial hemoglobin Concentration (gm\L) x arterial oxygen saturation x 1.34 The INTERVENTION will be blood transfusion targeting optimum systemic oxygen delivery So the TARGET HEMOGLOBIN LEVEL will be measured as Hb level = Systemic oxygen delivery (ml \ minute) / [(cardiac output (l\ minute) X arterial oxygen saturation x 1.34)] Then The required blood transfusion volume that will be given to cases is calculated according to the following one: volume of packed red blood cell =weight X (target hemoglobin -actual hemoglobin ) X 3/ hematocrit of packed red blood cell unit to be transfused 30
Control Group surviving sepsis campaign and hemoglobin level 24 hour The cardiac output will be measured by echocardiography. Blood transfusion will be given to controls targeting Hg level 10 gm/dl. If less, the required blood transfusion volume will be calculated from the following equation:volume of packed red blood cell =weight X (target hemoglobin -actual hemoglobin ) X 3 \ hematocrit of packed red blood cell unit 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Septic shock. Mechanically ventilated. Hemoglobinopathy and blood malignancies. Congenital heart disease. Severe respiratory disease with failure to achieve threshold arterial oxygen saturation 0.92. Chronic kidney disease. Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Month(s) 14 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 12/04/2018 Ethics Committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Resuscitation time Within 24 hour of PICU admission
Secondary Outcome Length of PICU stay till PICU discharge or death
Secondary Outcome Optimum systemic oxygen delivery achievement time. till Optimum systemic oxygen delivery achieved
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric intensive care unit El Shatby hospital Alexandria university Portsaid st, EL Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
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 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ahmed El nawawy 22 ElShatby Alexandria University Childrens Hospital Qesm Bab Sharqi Alexandria 21526 Egypt
Hadir Mohamed Hassouna 22 ElShatby Alexandria University Childrens Hospital Qesm Bab Sharqi Alexandria 21526 Egypt
Ali Abd Almouhsen 22 ElShatby Alexandria University Childrens Hospital Qesm Bab Sharqi Alexandria 21526 Egypt
Yasmine Elhusein Muhammed Muhammed 22 ElShatby Alexandria University Childrens Hospital Qesm Bab Sharqi Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed ElNawawy dr_anawawy@yahoo.com 002035919744 22 ElShatby Alexandria University Childrens Hospital Qesm Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor at pediatrics Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Ali Abdel Mohsen aly_elmohsen@yahoo.com 00201222621198 22 ElShatby Alexandria University Childrens Hospital Qesm Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor at 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
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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