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

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT04459572

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock Sepsis, Severe	Diagnostic Test: suPAR	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

The Investigation of Soluble Urokinase Plasminogen Activator Receptor (suPAR) as an Early Indicator of Prognosis and Mortality in Children With Sepsis and Septic Shock: A Prospective Study

Actual Study Start Date :

Mar 27, 2019

Actual Primary Completion Date :

Sep 27, 2019

Actual Study Completion Date :

Jun 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Sepsis and sepstic shock The study consists patients and healty-control group. Patients divided into 3 groups based on severity: sepsis, severe sepsis and septic shock	Diagnostic Test: suPAR Soluble Urokinase Plasminogen Activator Receptor (suPAR)

Arm

Intervention/Treatment

Other: Sepsis and sepstic shock

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

Diagnostic Test: suPAR

Soluble Urokinase Plasminogen Activator Receptor (suPAR)

Outcome Measures

Primary Outcome Measures

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