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CompletedNCT04459572suPARUpdated Jul 7, 2020

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

An interventional study of suPAR in Septic Shock and Sepsis, Severe, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Ege University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Mar 2019, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Septic Shock
  • Sepsis, Severe

Keywords

  • sepsis
  • suPAR
  • septic shock
  • children
  • mortality
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 72 is below the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • \<18 years
  • Admitted to emergency department with sepsis

Exclusion criteria

Exclusion Criteria:

  • >18 years
  • Diagnosed non-sepsis
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • 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

Interventions

  • Diagnostic testsuPAR

    Soluble Urokinase Plasminogen Activator Receptor (suPAR)

06

What researchers measure

Primary outcomes

  1. suPAR values in septic chock

    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

    Time frame: 7 days

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

07

Study locations

1 site
  • Ege University School of Medicine
    İzmir, 35100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04459572
Lead sponsor
Ege University
Responsible party
Caner Turan (Director, MD, Ege University) — Principal investigator
First posted
Jul 7, 2020
Start date
Mar 27, 2019
Primary completion
Sep 27, 2019
Completion
Jun 25, 2020
Last update
Jul 7, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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