Near Patient Molecular Testing in Sepsis

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission.

Detailed Description
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The ability of SeptiCyte RAPID to differentiate sepsis from infection-negative systemic inflammation will be determined using retrospective physician diagnosis performed by an external panel of three physicians not involved with the care of the patients.

Official Title
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Near Patient Molecular Testing in Sepsis

Conditions
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Sepsis, Systemic Inflammatory Response Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old on the date of ICU admission Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following: Temperature > 38°C or < 36°C Heart Rate > 90 beat/min Tachypnea > 20/min or PaCO2 < 32 mmHg WBC count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands) Consent to study inclusion, either by patient or legal surrogate before study-related sample processing Study sample collection within 24 hours of ICU admission order Exclusion Criteria: Age less than 18 years old on the day of ICU admission No order to admit to ICU Not physically admitted to ICU Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission Study sample collection > 24 hours from ICU admission order No clinical cultures or serologic tests obtained when sepsis was suspected Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours Transfer from another ICU where subject was admitted for ≥ 24 hours.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients sepsis suspected<br>Patients suspected of sepsis and admitted to ICU | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU. | Percentage of correctly identified patients with sepsis or non-infectious systemic inflammation using SeptiCyte RAPID compared to clinical assessments using routine clinical, laboratory, and other findings. | Time for enrollment, process samples, and collect data, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of diagnostic accuracy between SeptiCyte RAPID and up to 15 other clinical parameters in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU. | Multi-parametric model to compare diagnostic accuracy between SeptiCyte RAPID alone or in combination with up to 15 other clinical parameters. | Time for enrollment, process samples, and collect data, an average of 1 year |