Utility of Presepsin in Distinguishing Between Sepsis and SIRS
Completed
Conditions studied: SIRS, Sepsis
In brief
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).
Key facts
- Study ID
- NCT02052895
- Run by
- Mochida Pharmaceutical Company, Ltd.
- People needed
- 226
- Starts
- 2014-01-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2018-08-21
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female aged ≥ 21 years
- Appropriate clinical data to enable classification into sepsis or SIRS
- Written informed consent by the patient or legally authorized representative
- Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation
You may not qualify if…
- No informed consent
- Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
- Control
- Inclusion Criteria:
- Male or female aged ≥ 21 years
- Does not meet clinical criteria for sepsis or SIRS
- Written informed consent by the patient or legally authorized representative
- Exclusion Criteria:
- No informed consent
- Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
- End Stage Renal Disease
- Inclusion Criteria:
- Male or female aged ≥ 21 years
- Documented diagnosis of end stage renal disease currently undergoing dialysis
- Does not meet clinical criteria for sepsis or SIRS
- Written informed consent by the patient or legally authorized representative
- Exclusion Criteria:
- No informed consent
- Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
Where it is running
- Lahey Clinic — Boston, Massachusetts, United States
- Tufts Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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