Skip to main content
OpenTrials
Completed

NCT Number: NCT04459572

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University School of Medicine

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <18 years
  • Admitted to emergency department with sepsis

Exclusion criteria

  • >18 years
  • Diagnosed non-sepsis

Treatment and study plan

suPAR

Diagnostic Test

Soluble Urokinase Plasminogen Activator Receptor (suPAR)

Primary outcomes

  1. suPAR values in septic chock

    Time frame: 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 outcomes

  1. Presepsin level

    Time frame: 7 days

  2. C-Reactive Protein(CRP) level

    Time frame: 7 days

  3. Procalcitonin (PCT) level

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study 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

Acronym: suPAR

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.