Presepsin in the Diagnosis of Sepsis in Critically Ill Patients

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584594
• Other study ID #: KARIM-08-PSEPOVA
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Czechia	Public Health Institute Ostrava	Ostrava	Moravian-Silesian Region
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ostrava	Public Health Institute Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Okamura Y. [Usefulness of Presepsin Measurement: A New Biomarker for Sepsis]. Rinsho Byori. 2015 Jan;63(1):62-71. Japanese. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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