Presepsin in the Diagnosis of Sepsis in Critically Ill Patients

Prepepsin, the Improvement of the Early Inflammatory Biomarkers Strategy for the Diagnostics 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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Infection
• Intervention / Treatment: Diagnostic test: Presepsin measurement

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 702 00
      • Public Health Institute Ostrava
    • Ostrava, Moravian-Silesian Region, Czechia, 780 52
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a minimum 18 years admitted to ICU (surgical, traumatic, medical patients), who had proven criteria for sepsis, septic shock.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Presepsin assessment; 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.	Diagnostic test: Presepsin measurement; Presepsin measurements are performed with PathFast immunoassay analytical system on the ICU, bedside method. (Mitsubishi Chemical, Japan).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of Presepsin	Serum concentration of Presepsin in patients with sepsis or septic shock will be compared to PCT, IL6 and CRP results.	47 months
Area under the Receiver-operating characteristic Curve	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.	47 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of serum concentration of presepsin with detection of microbial agents	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.	47 months

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: Public Health Institute Ostrava
• Investigators: Principal Investigator: Marcela Káňová, MD,Ph.D., University Hospital Ostrava

Publications and helpful links

General Publications

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
• Masson S, Caironi P, Fanizza C, Thomae R, Bernasconi R, Noto A, Oggioni R, Pasetti GS, Romero M, Tognoni G, Latini R, Gattinoni L. Circulating presepsin (soluble CD14 subtype) as a marker of host response in patients with severe sepsis or septic shock: data from the multicenter, randomized ALBIOS trial. Intensive Care Med. 2015 Jan;41(1):12-20. doi: 10.1007/s00134-014-3514-2. Epub 2014 Oct 16. Erratum In: Intensive Care Med. 2015 Sep;41(9):1736.
• Zhang J, Hu ZD, Song J, Shao J. Diagnostic Value of Presepsin for Sepsis: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2015 Nov;94(47):e2158. doi: 10.1097/MD.0000000000002158.
• Ackland GL, Prowle JR. Presepsin: solving a soluble (CD14) problem in sepsis? Intensive Care Med. 2015 Feb;41(2):351-3. doi: 10.1007/s00134-014-3642-8. Epub 2015 Jan 22. No abstract available.
• Okamura Y. [Usefulness of Presepsin Measurement: A New Biomarker for Sepsis]. Rinsho Byori. 2015 Jan;63(1):62-71. Japanese.
• Rogic D, Juros GF, Petrik J, Vrancic AL. Advances and Pitfalls in Using Laboratory Biomarkers for the Diagnosis and Management of Sepsis. EJIFCC. 2017 May 1;28(2):114-121. eCollection 2017 May.
• Endo S, Suzuki Y, Takahashi G, Shozushima T, Ishikura H, Murai A, Nishida T, Irie Y, Miura M, Iguchi H, Fukui Y, Tanaka K, Nojima T, Okamura Y. Usefulness of presepsin in the diagnosis of sepsis in a multicenter prospective study. J Infect Chemother. 2012 Dec;18(6):891-7. doi: 10.1007/s10156-012-0435-2. Epub 2012 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; sepsis; diagnosis; presepsin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: KARIM-08-PSEPOVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The investigators have not decided to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No