Sepsis, Systemic Inflammatory Response Syndrome
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Rush University Medical Center
Grady Memorial Hospital
University of Southern California
Immunexpress
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old on the date of ICU admission 2. Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following: 1. Temperature \> 38°C or \< 36°C 2. Heart Rate \> 90 beat/min 3. Tachypnea \> 20/min or PaCO2 \< 32 mmHg 4. WBC count \> 12 000/mm3 or \< 4 000/mm3 or \> 10% immature neutrophils (bands) 3. Consent to study inclusion, either by patient or legal surrogate before study-related sample processing 4. Study sample collection within 24 hours of ICU admission order
Exclusion criteria
1. Age less than 18 years old on the day of ICU admission 2. No order to admit to ICU 3. Not physically admitted to ICU 4. Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission 5. Study sample collection \> 24 hours from ICU admission order 6. No clinical cultures or serologic tests obtained when sepsis was suspected 7. Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours 8. Transfer from another ICU where subject was admitted for ≥ 24 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU. | Time for enrollment, process samples, and collect data, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Time for enrollment, process samples, and collect data, an average of 1 year | Multi-parametric model to compare diagnostic accuracy between SeptiCyte RAPID alone or in combination with up to 15 other clinical parameters. |
Countries
United States
Outcome results
None listed