Utility of Presepsin in Distinguishing Between Sepsis and SIRS

Mochida Pharmaceutical

Status: Completed

Conditions: SIRS; Sepsis

Study type: Observational

Funder types: Industry

Identifiers

NCT02052895

IVD2001

Details and patient eligibility

About

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).

Enrollment: 226 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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%

Trial design

226 participants in 3 patient groups

Sepsis/SIRS

Description:

Patients with sepsis or SIRS

Control

Description:

Patients without SIRS, sepsis, or end stage renal disease

End Stage Renal Disease

Description:

Patients with end stage renal disease, without SIRS or sepsis