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.: PACTR201611001865365 Date of Approval: 13/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of central veno-arterial carbon dioxide difference as a complementary monitoring parameter in pediatric septic shock
Official scientific title Evaluation of central veno-arterial carbon dioxide difference as a valid resuscitation tool in pediatric shock
Brief summary describing the background and objectives of the trial Sepsis is a systemic, deleterious host response to infection leading to severe sepsis and septic shock.Severe sepsis and septic shock are major healthcare problems, killing one in four of people around the world each year, and increasing in incidence. There are very broad ranges of estimates for the incidence of sepsis in different countries. In the USA, based on hospital records, it ranged from 500000 to 660000 cases per year. The aim of this study was to evaluate the value of central veno-arterial carbon dioxide difference (¿PCO2) during early resuscitation and its relation to the outcomes of pediatric septic shock patients admitted to Alexandria University Pediatric Intensive Care Unit (PICU).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pediatric Septic Shock
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2014
Actual trial start date 01/03/2014
Anticipated date of last follow up 31/08/2014
Actual Last follow-up date 31/08/2014
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 98
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Low CO2 gap at time of central venous catheter insertion), and 6 ,12 ,24 hours after catheter insertion respectively. Central venous and arterial blood samples for blood gases were obtained 45 Active-Treatment of Control Group
Experimental Group High CO2 gap at time of central venous catheter insertion), and 6 ,12 ,24 hours after catheter insertion respectively. Central venous and arterial blood samples for blood gases were obtained 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- patients with a new episode of septic shock - fulfilling the criteria of the American College of Chest Physicians and the Society of Critical Care Medicine (ACCP/SCCM) Consensus Conference - admitted to the emergency room or proceeding from clinical wards. status asthmaticus, contraindication for central venous catheter (CVC) application or chronic blood transfusion, known pulmonary hypertension, all surgical and trauma patients, patients admitted ¿ 24 hours from the onset of first episode of sepsis induced hypotension Preschool Child: 2 Year-5 Year 3 Month(s) 50 Month(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 15/03/2014 Alexandria University IRB
Ethics Committee Address
Street address City Postal code Country
chambillion st. Azarita, Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Shock reversal time From admission till shock reversal (in hours)
Secondary Outcome Length of PICU stay, From admission to discharge or deceased
Secondary Outcome 28 day mortality From admission to discharge or deceased
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
Pediatric department, Faculty of Medicine, Alexandria University Portsaid street, El Shatby Alexandria 21563 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 Alexandria 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
Shimaa mohammad hasan mahmoud 124 Smouha compounds behind security directorate Alexandria 21615 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Nawawy dr_anawawy@yahoo.com 00201222621981 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 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Azza Moustafa Moustafa_azza@hotmail.com 002-01008948826 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Assistant Professor of pediatrics, Faculty of Medicine, University of Alexandria
REPORTING
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