Early Identification of Sepsis in Children

Brno University Hospital

Status: Unknown

Conditions: SIRS; Sepsis, Severe; Shock, Septic; Sepsis

Treatments: Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin

Study type: Observational

Funder types: Other

Identifiers

NCT03884595

FNBRNO-2017/01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 28 days to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 5 patient groups

No SIRS

Description:

Children without clinical signs of SIRS, according to Goldstein criteria.

Treatment:

Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin

SIRS

Description:

Children with clinical signs of SIRS, according to Goldstein criteria.

Treatment:

Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin

Sepsis

Description:

Children with clinical signs of sepsis, according to Goldstein criteria.

Treatment:

Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin

Severe sepsis

Description:

Children with clinical signs of severe sepsis, according to Goldstein criteria.

Treatment:

Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin

Septic Shock

Description:

Children with clinical signs of septic shock, according to Goldstein criteria.

Treatment:

Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin