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.: PACTR201703002089500 Date of Approval: 10/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Correlation between lactate/albumin ratio level and organ failure and mortality
Official scientific title Correlation between lactate/albumin ratio level and organ failure and mortality in pediatric sepsis and septic shock
Brief summary describing the background and objectives of the trial Sepsis is a major cause of pediatric intensive care unit (PICU) admission and is associated with high morbidity and mortality rates. Blood lactate concentrations have been used widely as a marker of altered tissue perfusion in critically ill patients. More recently, studies in septic patients have demonstrated an independent association between increasing serum lactate concentration with organ failure and mortality. The aim of our work is to study the association between lactate/albumin ratio level and the occurrence of organ failure and mortality in pediatric sepsis and septic shock .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Pediatric Septic Shock
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 01/02/2017
Actual Last follow-up date 01/02/2017
Anticipated target sample size (number of participants) 119
Actual target sample size (number of participants) 119
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 randomization (variable block size) 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 lactate/albumin ratio On admision, 6 hours and 24 hours Measurement of Lactate/albmin ratio 60
Experimental Group PIM2 On admission, 24 hours Measurement of PIM2 59 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sepsis Severe sepsis septic shock according to criteria of sepsis. - Children with myocardial infarction, pulmonary edema, hemorrhagic shock. - Children with trauma . - Chronic illness especially hepatic ,cardiac , renal diseases and muscle dystrophies. - All patients received albumin during their PICU stay. - patients with lactate level less than 2mmol/L at time of admission 2 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 21/09/2015 Faculty of Medicine, 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 28 day mortality From admission to discharge or deceased
Primary Outcome Shock reversal time From admission till shock reversal (in hours)
Primary Outcome Multi organ dysfunction syndrome From admission to discharge or deceased
Secondary Outcome Length of PICU stay, 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 Port Said street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric department, Faculty of Medicine, Alexandria University Port Said street, El Shatby Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric department, Faculty of Medicine, Alexandria University Port Said street, El Shatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Azza Ahmed Moustafa Port Said street, El Shatby Alexandria 21526 Egypt
Manal Abdel Malek Antonios Port Said street, El Shatby Alexandria 21526 Egypt
Eman Mohamed Ibraheem Port Said street, El Shatby Alexandria 21526 Egypt
Amna Hussein Mohamed Port Said street, El Shatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Azza Moustafa Moustafa_azza@hotmail.com 002-01008948826 Port said , EL Shatby
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Assistant Professor of Pediatrics, Head of PICU, 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 Ahmed El Nawawy dr_anawawy@yahoo.com +2 034831061 Port said , EL Shatby
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Professor of Pediatrics, Faculty of Medicine, University of Alexandria
REPORTING
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