The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS

Launched by IMMUNEXPRESS · Mar 4, 2016

Keywords

ClinConnect Summary

This study is evaluating a molecular diagnostic device developed to distinguish between sepsis and infection-negative SIRS among critically ill patients.

This study is a prospective, non-randomized, non-interventional, observational trial of patients with suspected sepsis in the medical and/or surgical wards. The study is being conducted on two preselected patient care units.

All patients identified by a local screening tool undergo physician review. If the suspicion of sepsis is found to be plausible, routine and conventional diagnostic procedures, including: routine bloods, blood cultur...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. 18-89 years old on the day of enrollment.
• • 2. Currently admitted to study designated medical or surgical ward
• • 3. Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool.
• • 4. Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool.
• • 5. Completed SBAR handover (Situation, Background, Assessment, Recommendation)
• 6. 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)
• Exclusion Criteria:
• • 1. Consent not provided
• • 2. Patients less than 18 years of age, or 90 years of age or older.
• • 3. Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis.
• • 4. Patients that are not located in the designated medical or surgical ward associated with the study.
• • 5. Patients listed for "Comfort Measures Only".
• • 6. Less than 2 SIRS criteria
• • 7. Commencement of narrow spectrum directed antibiotics prior to screening.