Utility of Presepsin in Distinguishing Between Sepsis and SIRS

Utility of Presepsin in Distinguishing Between Sepsis and SIRS (Systemic Inflammatory Response Syndrome): an Exploratory, Prospective Observational Study in Critically Ill Patients

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).

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%