Presepsin in the Diagnosis of Sepsis in Critically Ill Patients

University Hospital Ostrava

Status: Completed

Conditions: Infection; Sepsis

Treatments: Diagnostic Test: Presepsin measurement

Study type: Observational

Funder types: Other

Identifiers

NCT03584594

KARIM-08-PSEPOVA

Details and patient eligibility

About

Sepsis is one of the most common causes of death worldwide. It is caused by a complex of inadequate host responses to infection. Sepsis remains a major challenge of modern intensive care medicine. Despite recent improvements, the incidence of sepsis in critically ill patients increases steadily (25%) and mortality rates remain unacceptably high (30%). It is difficult to distinguish the sepsis from the non-infectious systemic inflammatory response syndrome. Early identification of the origin of infection can help dramatically to improve outcome and reduce mortality. That is why clinicians need fast, reliable and specific biomarkers for sepsis recognition.

Full description

Comparison between the detection of novel early inflammatory biomarker (PSEP) and the others normally used biomarkers (c-reactive protein - CRP, interleukin 6 - IL6, procalcitonin - PCT) in the early diagnosing of sepsis in the critically ill patients A broad range of clinical and laboratory parameters are combined (Surviving sepsis campaign, international guidelines) for early sepsis identification: white blood cells (WBC), C-reactive protein (CRP), interleukin 6 (IL-6), procalcitonin (PCT).

An ideal biomarker should be a fast and specific increase in sepsis, short half-life, rapid decrease after administration of an effective therapy and fast (bed-side) method of determination. None of the current biomarkers have all of these characteristics.

We investigate the diagnostic accuracy of presepsin compared to other biomarkers (WBC, PCT, IL6, CRP) for infection or sepsis, defined according to Sepsis-3 definition (Singer, JAMA 2016) in adult patients admitted to ICU with suspected sepsis.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed informed consent
• diagnosis of sepsis from qSOFA (quick Subsequent Organ Failures Assessment)
• need of vasopressors for mean arterial pressure (MAP) ≥ 65 mmHg
• lactate levels ≥ 2mmol/l despite adequate volume resuscitation

Exclusion criteria

• age below 18 years
• terminal state of disease
• pregnancy

Trial design

200 participants in 1 patient group

Presepsin assessment

Description:

Residual blood samples after performing all necessary blood examinations and analyses will be used to determine the level of presepsin, as the potential new biomarker of infection.

Treatment:

Diagnostic Test: Presepsin measurement