Utility of Presepsin in Distinguishing Between Sepsis and SIRS

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052895
• Other study ID #: IVD2001
• Status: Completed
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2018
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• 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%

Related Conditions & MeSH terms

• Sepsis
• SIRS
• Systemic Inflammatory Response Syndrome
• Toxemia

Locations

Country	Name	City	State
United States	Lahey Clinic	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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