N/A
Completed N=226
Utility of Presepsin in Distinguishing Between Sepsis and SIRS
SIRS · Sepsis
Source: ClinicalTrials.gov NCT02052895 ↗
Enrolled (actual)
226
Serious AEs
11.8%
Results posted
Sep 2016
Primary outcomePrimary: Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis — 0.7218; 0.6901 probability — p=0.3924
Summary
This is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and SIRS upon presentation with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis |
0.7218; 0.6901 | 0.3924 |
Eligibility Criteria
Sepsis/SIRS Patients
Inclusion Criteria
- Male or female aged ≥ 21 years
- Appropriate clinical data to enable classification into sepsis or SIRS
- Written informed consent by the patient or legally authorized representative
- Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation
Exclusion Criteria
- No informed consent
- Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
Control
Inclusion Criteria
- Male or female aged ≥ 21 years
- Does not meet clinical criteria for sepsis or SIRS
- Written informed consent by the patient or legally authorized representative
Exclusion Criteria
- No informed consent
- Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
End Stage Renal Disease
Inclusion Criteria
- Male or female aged ≥ 21 years
- Documented diagnosis of end stage renal disease currently undergoing dialysis
- Does not meet clinical criteria for sepsis or SIRS
- Written informed consent by the patient or legally authorized representative
Exclusion Criteria
- No informed consent
- Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
Data sourced from ClinicalTrials.gov (NCT02052895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.