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
|Condition or disease||Intervention/treatment|
|Sepsis Infection||Diagnostic Test: Presepsin measurement|
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|
|Estimated Enrollment :||200 participants|
|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|
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).
- 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.
- 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.
- 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
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
|Contact: Petr Vávra, Ass.Prof.,MD,Ph.D.||0042059737 ext firstname.lastname@example.org|
|Contact: Jiří Hynčica||0042059737 ext email@example.com|
|Public Health Institute Ostrava||Recruiting|
|Ostrava, Moravian-Silesian Region, Czechia, 702 00|
|Contact: Radim Dobiáš, Mgr. 0042059620 ext 0239 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Jiří Hynčica 0042059737 ext 2587 firstname.lastname@example.org|
|Principal Investigator: Marcela Káňová, MD, Ph.D.|
|Principal Investigator:||Marcela Káňová, MD,Ph.D.||University Hospital Ostrava|