Sepsis, SIRS
Conditions
Keywords
Presepsin, Sepsis, SIRS
Brief 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).
Interventions
None listed
Sponsors
Mochida Pharmaceutical Company, Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis | Up to 7 days | For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sepsis/SIRS Patients with sepsis or SIRS | 190 |
| Control Patients without SIRS, sepsis, or end stage renal disease | 15 |
| End Stage Renal Disease Patients with end stage renal disease, without SIRS or sepsis | 15 |
| Total | 220 |
Baseline characteristics
| Characteristic | Sepsis/SIRS | Control | End Stage Renal Disease | Total |
|---|---|---|---|---|
| Age, Continuous | 58.80 years STANDARD_DEVIATION 15.99 | 65.80 years STANDARD_DEVIATION 13.11 | 53.70 years STANDARD_DEVIATION 19.5 | 59.00 years STANDARD_DEVIATION 16.02 |
| Sex: Female, Male Female | 73 Participants | 6 Participants | 9 Participants | 88 Participants |
| Sex: Female, Male Male | 117 Participants | 9 Participants | 6 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 190 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 26 / 190 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis
For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.
Time frame: Up to 7 days
Population: Out of 196 Sepsis/SIRS patients, 6 were excluded due to inclusion/exclusion criteria violation and 4 were excluded due to insufficient data for Sepsis/SIRS adjudication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Presepsin | Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis | 0.7218 probability |
| Procalcitonin | Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis | 0.6901 probability |
p-value: 0.392495% CI: [-0.0409, 0.1043]Regression, Logistic