Utility of Presepsin in Distinguishing Between Sepsis and SIRS

NCT02052895 | Completed Results

• 1 other identifier: IVD2001
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 2

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).

Conditions

SIRS; Sepsis

Keywords

Presepsin; Sepsis; SIRS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• No informed consent
• Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%
• Control
• 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
• No informed consent
• Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%
• End Stage Renal Disease
• 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
• No informed consent
• Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

Sponsors & Collaborators

• Mochida Pharmaceutical Company, Ltd.: lead

Study Sites (2)

Lahey Clinic

Boston, Massachusetts, 01805, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma Blood serum

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hironori Sato
• Organization: Mochida Pharmaceutical

hnsato@mochida.co.jp

+81-3-3225-6331

Study Officials

• Stanley Nasraway, MD, FCCM

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 21, 2018
• Results First Posted: September 27, 2016

Record last verified: 2018-08

Locations

US (2)