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

Septic Shock Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459572
• Other study ID #: TGA-2019-20230
• Status: Completed
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: June 25, 2020

Study information

• Verified date: July 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 25, 2020
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• <18 years

• Admitted to emergency department with sepsis

Exclusion Criteria:

• >18 years

• Diagnosed non-sepsis

Related Conditions & MeSH terms

• Sepsis
• Sepsis, Severe
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Diagnostic Test:
• suPAR
Soluble Urokinase Plasminogen Activator Receptor (suPAR)

Locations

Country	Name	City	State
Turkey	Ege University School of Medicine	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presepsin level		7 days
Secondary	C-Reactive Protein(CRP) level		7 days
Secondary	Procalcitonin (PCT) level		7 days