Back to results

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

Primary Purpose

Septic Shock, Sepsis, Severe

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

suPAR

About this trial

This is an interventional diagnostic trial for Septic Shock focused on measuring sepsis, suPAR, septic shock, children, mortality

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

<18 years
Admitted to emergency department with sepsis

Exclusion Criteria:

>18 years
Diagnosed non-sepsis

Sites / Locations

Ege University School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sepsis and sepstic shock

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Presepsin level

C-Reactive Protein(CRP) level

Procalcitonin (PCT) level

Full Information

NCT ID

NCT04459572

First Posted

June 30, 2020

Last Updated

July 6, 2020

Sponsor

Ege University

1. Study Identification

Unique Protocol Identification Number

NCT04459572

Brief Title

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

Acronym

suPAR

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

March 27, 2019 (Actual)

Primary Completion Date

September 27, 2019 (Actual)

Study Completion Date

June 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock, Sepsis, Severe

Keywords

sepsis, suPAR, septic shock, children, mortality

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sepsis and sepstic shock

Arm Type

Other

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

suPAR

Intervention Description

Soluble Urokinase Plasminogen Activator Receptor (suPAR)

Primary Outcome Measure Information:

Title

suPAR values in septic chock

Description

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 Outcome Measure Information:

Title

Presepsin level

Time Frame

7 days

Title

C-Reactive Protein(CRP) level

Time Frame

7 days

Title

Procalcitonin (PCT) level

Time Frame

7 days

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: <18 years Admitted to emergency department with sepsis Exclusion Criteria: >18 years Diagnosed non-sepsis

Facility Information:

Facility Name

Ege University School of Medicine

City

İzmir

ZIP/Postal Code

35100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs