The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS
Stopped early
Conditions studied: Sepsis, SIRS
In brief
A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS
Key facts
- Study ID
- NCT02704871
- Run by
- Immunexpress
- People needed
- 66
- Starts
- 2015-06-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2018-03-01
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-89 years old on the day of enrollment.
- Currently admitted to study designated medical or surgical ward
- Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool.
- Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool.
- Completed SBAR handover (Situation, Background, Assessment, Recommendation)
- 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)
You may not qualify if…
- Consent not provided
- Patients less than 18 years of age, or 90 years of age or older.
- Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis.
- Patients that are not located in the designated medical or surgical ward associated with the study.
- Patients listed for "Comfort Measures Only".
- Less than 2 SIRS criteria
- Commencement of narrow spectrum directed antibiotics prior to screening.
Where it is running
- Rhode Island Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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