Utility of Presepsin in Distinguishing Between Sepsis and SIRS

Completed

• Conditions: SIRS; Sepsis

• Registration Number: NCT02052895
• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-08-04
• Results First Submitted QC: 2016-08-04
• Results First Posted: 2016-09-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-19
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis	Up to 7 days	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.

Trial Locations

Locations (2)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Lahey Clinic; 🇺🇸 Boston, Massachusetts, United States