Utility of Presepsin in Children Sepsis

NCT02643121 | Unknown

• 1 other identifier: KDAR 19 - 1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Presepsin (formerly CD14), is a glycoprotein receptor occurring at the surface of monocytes/macrophages. CD14 binds to lipopolysaccharide (LPS) complexes and LPS binding protein (LPB), which triggers the activation of toll-like receptor 4 (TLR4), resulting in the production of numerous pro-inflammatory cytokines. Following Presepsin activation by bacterial products, the CD14 complex is released in the circulation as its soluble form (sCD14), which in turn is cleaved by a plasma protease to generate a sCD14 fragment called sCD14-subtype (sCD14- ST). Plasma levels of sCD14 can be measured using an automated chemo-luminescent assay (PATHFAST).

Conditions

Sepsis Syndrome

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of presepsin

  Assessed the presepsin diagnostic accuracy of presepsin in diagnosing children sepsis and in discriminating systemic inflammatory response syndrome (SIRS) from sepsis. Diagnostic accuracies presented as area under the curve (AUC) for sCD14-ST.

  up to 36 months

Secondary Outcomes (1)

• Prognostic value of presepsin

  up to 36 months

Other Outcomes (1)

• Mortality

  up to 36 months

Study Arms (2)

children with sepsis, SIRS

Data will be collected and analyzed from childrens with SIRS or septic state who will be admitted to the Department of Anesthesia and Intensive Care of the University Children´s Hospital Brno, Czech Republic. Infections, sepsis, severe sepsis, septic shock and multiple organ dysfunction syndrome (MODS) will be defined according to commonly used criteria - by International pediatric sepsis consensus conference.

Other: therapy sepsis

control group, healthy children

The samples children undergoing elective surgery will be used as a controls, i.e. samples from patients without signs of infection.

Interventions

therapy sepsis OTHER

Treatment of sepsis varies depending on the site and cause of the initial infection, the organs affected and the extent of any damage

children with sepsis, SIRS

Eligibility Criteria

• Age: 1 Month - 216 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Childrens with SIRS or septic state who will be admitted to the Department of Anesthesia and Intensive Care of the University Children´s Hospital Brno, Czech Republic. Infections, sepsis, severe sepsis, septic shock and multiple organ dysfunction syndrome (MODS) will be defined according to commonly used criteria - by International pediatric sepsis consensus conference. The samples from children undergoing elective surgery will be used as a controls, i.e. samples from patients without signs of infection.

You may qualify if:

• children aged 1 - 216 months
• clinical data to enable classification into sepsis or SIRS
• written informed consent by the legally authorized representative

You may not qualify if:

• no informed consent
• Control
• children aged 1 - 216 months
• does not meet clinical criteria for sepsis or SIRS
• written informed consent by the legally authorized representative
• no informed consent

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Faculty Hospital Brno

Brno, 625 00, Czechia

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Jiří Žurek, M.D., Ph.D.

  Department of Anesthesia and Intensive Care, University Children´s Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

CZ (1)