Sepsis Clinical Trial
Official title:
Early Identification of Sepsis in Children
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.
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.
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