Early Identification of Sepsis in Children

Study Overview
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Brief Summary
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This observational nation-wide study is focused on evaluation of the new possible biomarkers for pediatric sepsis and their specificity/sensitivity in combination with usual diagnostic markers for sepsis in the terms of early identification of sepsis, severe sepsis, and septic shock.

Detailed Description
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The understanding of sepsis pathophysiology underwent a great progress during the last decades and the therapy of sepsis is in the focus of the research for many years, but sepsis is still one of the main causes of death in the ICUs around the world. Systemic inflammatory response syndrome (SIRS) is closely connected with the sepsis development, but SIRS also represents a high risk of organ dysfunction in non-infectious patients (trauma, stress, cardiopulmonary arrest). Early diagnosis and prevention of the organ dysfunction are the mainstay of the correct and timely therapy, but currently there is no reliable, quick and simple method for the diagnosis of sepsis. And also there is no generally accepted clinical or laboratory parameter, which can be used to differentiate between sepsis and SIRS. There are some commonly available biomarkers that showed promising results in critically ill adult patients. Those include immature platelet fraction (IPF), immature granulocytes (IG) count and nucleated red blood cells (NRBC) count. The knowledge of their variability in different phases of illness (SIRS/sepsis/severe sepsis/septic shock) in pediatric patients is very limited, as is their connection with other generally used markers of infection (CRP, procalcitonin, presepsin). This study is strictly non-interventional and focused on usability of above mentioned biomarkers in the early diagnosis of sepsis/SIRS and on the reduction of morbidity/mortality of pediatric intensive care unit (PICU) patients with sepsis/SIRS. In all patients admitted to PICU in selected study period, the inflammation markers - C-reactive protein (CRP), procalcitonin (PCT), presepsin (soluble cluster of differentiation 14-subtypes) and full blood count parameters -IPF,IG,NRBC will be measured at the time of admission and on 3rd, 5th and 7th day of stay in intensive care. The organ dysfunction score will be evaluated daily.

Official Title
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Early Identification of Sepsis in Children

Conditions
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Sepsis, Shock, Septic, Sepsis, Severe, SIRS

Intervention / Treatment
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* Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients admitted to PICU until the 18th year of age expected length of stay > 48 hours Exclusion Criteria: oncology patients immunosuppressive therapy immunostimulant therapy autoimmune disease post-organ transplant patient thrombocytopaenia, thrombocytopathy

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No SIRS<br>Children without clinical signs of SIRS, according to Goldstein criteria. | Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin<br>* Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.<br>|
| SIRS<br>Children with clinical signs of SIRS, according to Goldstein criteria. | Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin<br>* Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.<br>|
| Sepsis<br>Children with clinical signs of sepsis, according to Goldstein criteria. | Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin<br>* Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.<br>|
| Severe sepsis<br>Children with clinical signs of severe sepsis, according to Goldstein criteria. | Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin<br>* Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.<br>|
| Septic Shock<br>Children with clinical signs of septic shock, according to Goldstein criteria. | Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin<br>* Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IG and IPF concentration for early sepsis identification | The levels of IG and IPF will be obtained in first 7 days after admission. The IG and IPF will be evaluated for the possibility of early sepsis recognition. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IG serum levels in patients with SIRS and sepsis/severe sepsis/septic shock | The levels of IG will be obtained in first 7 days after admission. The IG will be evaluated for the possibility of distinguish patients with or without SIRS and sepsis/severe sepsis/septic shock sepsis/septic shock. | 7 days | 
| IPF serum levels in patients with SIRS and sepsis/severe sepsis/septic shock | The levels of IPF will be obtained in first 7 days after admission. The IPF will be evaluated for the possibility of distinguish patients with or without SIRS and sepsis/severe sepsis/septic shock sepsis/septic shock. | 7 days | 
| NRBC cell count and critically ill patient´s outcome | The NRBC count will be obtained in first 7 days after admission. The NRBC count will be evaluated for the possibility correlation with the outcome (mortality and morbidity) of critically ill paediatric patients in PICU sepsis/septic shock? | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, septic shock, severe sepsis, SIRS, children, immature platelet fraction (IPF), immature granulocytes (IG), nucleated red blood cells (NRBC)