Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis

• Conditions: Sepsis; Sepsis With Acute Organ Dysfunction; Septic Shock

• Registration Number: NCT03113721
• Lead Sponsor: Axis Shield Diagnostics Ltd

Brief Summary

The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission.

Detailed Description

The primary objective of this study is to use HBP concentration to indicate the presence, or outcome, of severe sepsis (including septic shock) at admission and to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission.

The secondary objectives of this study are to separately evaluate the performance of HBP concentration to a) indicate the presence of severe sepsis (including severe sepsis) at admission and b) to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission.

Further exploratory objectives include evaluating the use of HBP measurement to indicate the outcome of severe sepsis (including septic shock) in patients with suspected infection 12-24 hours after emergency department admission, to compare the use of HBP to other markers of severe infection and to evaluate whether or not different cut-off values are required for the progression and outcome measures.

Study Timeline

• Study First Submitted: 2017-03-24
• Study Start: 2017-03-27
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Primary Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 571

Inclusion Criteria

• >18 years of age, suspected infection

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of plasma levels of HBP to evaluate patients with suspected infection for their risk of developing severe sepsis	72 hours	The purpose of this measurement is to assess the clinical validity of plasma levels of HBP for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission. The concentration of plasma HBP will be compared to the final clinical outcome of the patient to assess the ability of the HBP level to predict clinical progression.

Trial Locations

Locations (5)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States

York Hospitals; 🇺🇸 York, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States