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NCT Number: NCT03584594

Presepsin in the Diagnosis of Sepsis in Critically Ill Patients

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.

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Key information

Conditions

Sepsis Disease Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Public Health Institute Ostrava, Ostrava, Moravian-Silesian Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Presepsin measurement

Diagnostic Test

Presepsin measurements are performed with PathFast immunoassay analytical system on the ICU, bedside method. (Mitsubishi Chemical, Japan).

Primary outcomes

  1. Serum concentration of Presepsin

    Time frame: 47 months

    Serum concentration of Presepsin in patients with sepsis or septic shock will be compared to PCT, IL6 and CRP results.

  2. Area under the Receiver-operating characteristic Curve

    Time frame: 47 months

    Area under the Receiver-operating characteristic Curve (ROC-AUC) of the presepsin and other biomarkers (PCT, IL6, CRP) for diagnostic value of any biomarker will be analysed on a scale 0-100.

Secondary outcomes

  1. Correlation of serum concentration of presepsin with detection of microbial agents

    Time frame: 47 months

    Comparison of presepsin concentration in serum with the results of culture/microscopy of a pathogen from a clinical focus using methods of classical microbiology. In patients with risk factors for invasive mycosis, comparison of presepsin concentration with serum for galactomannan (GM) and beta- D- glucan (BG) detection will be performed.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Public Health Institute Ostrava

Registry information

Official study title

Prepepsin, the Improvement of the Early Inflammatory Biomarkers Strategy for the Diagnostics of Sepsis in Critically Ill Patients

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 12, 2018
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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