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).

Study Overview

• Status: Completed
• Conditions: Sepsis; SIRS

• Study Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 01805
      • Lahey Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with presentation to ICU with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).

Description

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%

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Sepsis/SIRS; Patients with sepsis or SIRS
Control; Patients without SIRS, sepsis, or end stage renal disease
End Stage Renal Disease; Patients with end stage renal disease, without SIRS or sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mochida Pharmaceutical Company, Ltd.
• Investigators: Principal Investigator: Stanley Nasraway, MD, FCCM, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (ESTIMATE): February 3, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 19, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Sepsis; SIRS; Presepsin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: IVD2001