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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepsis/SIRS | Patients with sepsis or SIRS | ||
| Control | Patients without SIRS, sepsis, or end stage renal disease | ||
| End Stage Renal Disease | Patients with end stage renal disease, without SIRS or sepsis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 days |
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Sepsis/SIRS Patients
Inclusion Criteria:
Exclusion Criteria:
Control
Inclusion Criteria:
Exclusion Criteria:
End Stage Renal Disease
Inclusion Criteria:
Exclusion Criteria:
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Subjects with presentation to ICU with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Nasraway, MD, FCCM | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic | Boston | Massachusetts | 01805 | United States | ||
| Tufts Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sepsis/SIRS | Patients with sepsis or SIRS |
| FG001 | Control | Patients without SIRS, sepsis, or end stage renal disease |
| FG002 | End Stage Renal Disease | Patients with end stage renal disease, without SIRS or sepsis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who didn't meet inclusion/exclusion criteria were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sepsis/SIRS | Patients with sepsis or SIRS |
| BG001 | Control | Patients without SIRS, sepsis, or end stage renal disease |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | probability | Up to 7 days |
|
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Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sepsis/SIRS | Patients with sepsis or SIRS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hironori Sato | Mochida Pharmaceutical | +81-3-3225-6331 | hnsato@mochida.co.jp |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Blood plasma Blood serum
| Boston |
| Massachusetts |
| 02111 |
| United States |
| BG002 | End Stage Renal Disease | Patients with end stage renal disease, without SIRS or sepsis |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
ROC-AUC of procalcitonin for discriminating between Sepsis and SIRS |
|
|
|
| 26 |
| 190 |
| 0 |
| 190 |
| EG001 | Control | Patients without SIRS, sepsis, or end stage renal disease | 0 | 15 | 0 | 15 |
| EG002 | End Stage Renal Disease | Patients with end stage renal disease, without SIRS or sepsis | 0 | 15 | 0 | 15 |
| Gastrointestinal hemmorage | Gastrointestinal disorders |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
|
| Hemorrhage | Vascular disorders |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 50 days from the time submitted to the sponsor for review. Only if the disclosure becomes an obstacle to the sponsor's business or registration or maintenance of the sponsor's invention, the sponsor may require changes to the communication and may extend the embargo.
| D013568 |
| Pathological Conditions, Signs and Symptoms |