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

NCT04459572 | Completed

• 1 other identifier: TGA-2019-20230
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Sepsis, Severe

Keywords

sepsis; suPAR; septic shock; children; mortality

Outcome Measures

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

  7 days

Secondary Outcomes (3)

• Presepsin level

  7 days

• C-Reactive Protein(CRP) level

  7 days

• Procalcitonin (PCT) level

  7 days

Study Arms (1)

Sepsis and sepstic shock

OTHER

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

suPAR DIAGNOSTIC_TEST

Soluble Urokinase Plasminogen Activator Receptor (suPAR)

Sepsis and sepstic shock

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \>18 years
• Diagnosed non-sepsis

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University School of Medicine

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MD

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: March 27, 2019
• Primary Completion: September 27, 2019
• Study Completion: June 25, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)