Presepsin in the Diagnosis of Sepsis in Critically Ill Patients

NCT03584594 | Completed

• 1 other identifier: KARIM-08-PSEPOVA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sepsis; Infection

Keywords

presepsin; biomarkers; sepsis; diagnosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Correlation of serum concentration of presepsin with detection of microbial agents

  47 months

Study Arms (1)

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

Interventions

Presepsin measurement DIAGNOSTIC_TEST

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

Presepsin assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Public Health Institute Ostrava: collaborator

Study Sites (2)

Public Health Institute Ostrava

Ostrava, Moravian-Silesian Region, 702 00, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 780 52, Czechia

Location

Related Publications (7)

• 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.

  PMID: 26903338 BACKGROUND

• 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.

  PMID: 25319385 BACKGROUND

• 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.

  PMID: 26632748 BACKGROUND

• 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.

  PMID: 25608923 BACKGROUND

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

  PMID: 26524880 BACKGROUND

• 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.

  PMID: 28757819 BACKGROUND

• 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.

  PMID: 22692596 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual blood samples remaining after performing all necessary standard and indicated blood examinations and analyses will be used to determine the level of presepsin, as the potential new biomarker of sepsis in critically ill patients.

MeSH Terms

Conditions

Sepsis; Infections; Disease

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcela Káňová, MD,Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 12, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: March 30, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CZ (2)