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Presepsin in the Diagnosis of Sepsis in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03584594
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Public Health Institute Ostrava
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease Intervention/treatment
Sepsis Infection 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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prepepsin, the Improvement of the Early Inflammatory Biomarkers Strategy for the Diagnostics of Sepsis in Critically Ill Patients
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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.


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584594


Contacts
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Contact: Petr Vávra, Ass.Prof.,MD,Ph.D. 0042059737 ext 2544 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
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Czechia
Public Health Institute Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 702 00
Contact: Radim Dobiáš, Mgr.    0042059620 ext 0239    radim.dobias@zuova.cz   
Principal Investigator: Radim Dobiáš, Mgr.         
University Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 780 52
Contact: Petr Vávra, Ass.Prof.,MD,Ph.D.    0042059737 ext 2544    petr.vavra@fno.cz   
Contact: Jiří Hynčica    0042059737 ext 2587    jiri.hyncica@fno.cz   
Principal Investigator: Marcela Káňová, MD, Ph.D.         
Sponsors and Collaborators
University Hospital Ostrava
Public Health Institute Ostrava
Investigators
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Principal Investigator: Marcela Káňová, MD,Ph.D. University Hospital Ostrava

Publications:

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03584594     History of Changes
Other Study ID Numbers: KARIM-08-PSEPOVA
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators have not decided to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Ostrava:
presepsin
biomarkers
sepsis
diagnosis

Additional relevant MeSH terms:
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Sepsis
Toxemia
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes