Sepsis Clinical Trial
Official title:
Utility of Presepsin in Distinguishing Between Sepsis and SIRS (Systemic Inflammatory Response Syndrome): an Exploratory, Prospective Observational Study in Critically Ill Patients
NCT number | NCT02052895 |
Other study ID # | IVD2001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | July 2015 |
Verified date | August 2018 |
Source | Mochida Pharmaceutical Company, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 226 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Sepsis/SIRS Patients Inclusion Criteria: - 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 Exclusion Criteria: - 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% |
Country | Name | City | State |
---|---|---|---|
United States | Lahey Clinic | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mochida Pharmaceutical Company, Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis | For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin. | Up to 7 days |
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