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Biomarkers for Sepsis in Childre

Not Applicable
Conditions
sepsis
Infection - Other infectious diseases
Registration Number
ACTRN12624000782538
Lead Sponsor
Murdoch Children's Research Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
240
Inclusion Criteria

•Aged <18 years; AND
•Admission to hospital; AND
•Treatment with intravenous (IV)/ intramuscular (IM)/ intraosseous (IO) antibiotics pre-hospital or in ED; AND
•Circulatory support (fluid bolus or inotropic support) pre-hospital or in ED
OR
Admission diagnosis of suspected sepsis, septicaemia or septic shock

Fluid bolus defined as equal to or greater than 5ml/kg or 500mls administered over less than or equal to 30 minutes to treat impaired perfusion (not dehydration)
Inotropic support defined as intravenous infusion of inotrope/vasopressor

Exclusion Criteria

a)Patients not initially seen in the Emergency Department (i.e. transferred to the ward including ICU)
b)Patients presenting with trauma who receive antibiotics for prophylaxis or circulatory support for blood loss
c)Patients transferred from another hospital if > 24 hours since presentation
d)Patients transferred from another hospital ward to ED

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ovel biomarker for early sepsis diagnosis[Novel biomarkers will be identified from discard blood samples taken during routine clinical care of children with suspected sepsis. Once the patients diagnosis is known, the samples will be analysed and compared with healthy controls to discover, validate, and verify suitability for commercialisation. Blood samples will be taken during routine initial investigations for children with suspected sepsis as per normal clinical care. Instead of the samples being discarded following laboratory analysis, they will be stored at -80 degrees celcius. Consent for biomarker analysis will be obtained, and once the patient diagnosis is known, the samples will be analysed for mRNA and protein signatures.]
Secondary Outcome Measures
NameTimeMethod
ovel biomarkers for risk stratification of children with sepsis[Novel biomarkers will be identified from discard blood samples taken during routine clinical care of children with suspected sepsis. Once the patients illness severity is known, the samples will be analysed and compared with healthy controls to discover, validate, and verify suitability for commercialisation. Blood samples will be taken during routine initial investigations for children with suspected sepsis as per normal clinical care. Instead of the samples being discarded following laboratory analysis, they will be stored at -80 degrees celcius. Consent for biomarker analysis will be obtained, and once the patients severity of illness is known, the samples will be analysed for mRNA and protein signatures.]
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