As an Early Indicator Biomarker of Prognosis and Mortality in Children With Sepsis and Septic Shock: suPAR

Not Applicable

Completed

• Conditions: Septic Shock; Sepsis, Severe
• Interventions: Diagnostic Test: suPAR

• Registration Number: NCT04459572
• Lead Sponsor: Ege University

Brief Summary

The sepsis and septic shock remain major causes of child morbidity and mortality, despite the use of modern antibiotics and resuscitation therapies. Recent interest has focused on biomarkers for early diagnosis, and evaluation the outcomes of sepsis; but there is a still lack of early diagnosis and timely intervention for sepsis in the emergency department (ED). The primary aim was to investigate the role of C-Reactive Protein(CRP), Procalcitonin(PCT), soluble-urokinase plasminogen activator receptor(suPAR) and Presepsin in the early stratification of patients with sepsis. The usefulness of pediatric Sequential Organ Failure Assessment (pSOFA) for predicting of the mortality and the rate of PICU admission in children with septik shock were also investigated. This prospective pilot study was conducted at academic pediatric ED between September 2017-June 2018. All children who met sepsis criteria admitted to ED were involved to study. They kept following up after ED management and their blood samples were taken upon admission on day 0, 1, 2, 4 and 7. The definition made as sepsis, severe sepsis and septic shock. At the same period, 100 healthy children chosen as the control group. The patient characteristics, clinical features, diagnosis, co-morbidities, source of infection, laboratory results (CRP, PCT, lactate, suPAR and Presepsin) and treatments were recorded. The pSOFA score was calculated during first hour of admission. Length of stay in ED and hospital was noted. The main outcome measure was in 7 and 30-day mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-27
• Primary Completion: 2019-09-27
• Study Completion: 2020-06-25
• Study First Submitted: 2020-06-30
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• <18 years
• Admitted to emergency department with sepsis

Exclusion Criteria

• >18 years
• Diagnosed non-sepsis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sepsis and sepstic shock	suPAR	The study consists patients and healty-control group. Patients divided into 3 groups based on severity: sepsis, severe sepsis and septic shock

Primary Outcome Measures

Name	Time	Method
suPAR values in septic chock	7 days	The usefulness of soluble urokinase type plasminogen activator receptor (suPAR) for predicting of the mortality and the rate of PICU admission in children with septik shock

Secondary Outcome Measures

Name	Time	Method
Procalcitonin (PCT) level	7 days
Presepsin level	7 days
C-Reactive Protein(CRP) level	7 days

Trial Locations

Locations (1)

Ege University School of Medicine; 🇹🇷 İzmir, Turkey