Early Identification of Sepsis in Children

• Conditions: SIRS; Sepsis, Severe; Shock, Septic; Sepsis
• Interventions: Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin

• Registration Number: NCT03884595
• Lead Sponsor: Brno University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Status Verified: 2019-12
• Study Start: 2019-12-01
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03
• Primary Completion: 2021-12
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis	IG, IPF, NRBC, CRP, PCT, presepsin	Children with clinical signs of sepsis, according to Goldstein criteria.
No SIRS	IG, IPF, NRBC, CRP, PCT, presepsin	Children without clinical signs of SIRS, according to Goldstein criteria.
Septic Shock	IG, IPF, NRBC, CRP, PCT, presepsin	Children with clinical signs of septic shock, according to Goldstein criteria.
SIRS	IG, IPF, NRBC, CRP, PCT, presepsin	Children with clinical signs of SIRS, according to Goldstein criteria.
Severe sepsis	IG, IPF, NRBC, CRP, PCT, presepsin	Children with clinical signs of severe sepsis, according to Goldstein criteria.

Primary Outcome Measures

Name	Time	Method
IG and IPF concentration for early sepsis identification	7 days	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.

Secondary Outcome Measures

Name	Time	Method
IG serum levels in patients with SIRS and sepsis/severe sepsis/septic shock	7 days	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.
IPF serum levels in patients with SIRS and sepsis/severe sepsis/septic shock	7 days	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.
NRBC cell count and critically ill patient´s outcome	7 days	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?

Trial Locations

Locations (1)

University Hospital Brno; 🇨🇿 Brno, Czechia