Clinical trial NCT03113721: Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis
Official title: Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the HBP Assay to Predict Development of Severe Sepsis in Patients With Suspected Infection Following ED Admission
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Sepsis With Acute Organ Dysfunction
Lead sponsor: Axis Shield Diagnostics Ltd
Sponsor class: INDUSTRY
Collaborators: name: Drexel University
name: York Hospitals
name: Jefferson Medical College of Thomas Jefferson University
name: Vanderbilt University Medical Center
name: Baylor College of Medicine
First posted: 2017-04-13
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (greater than 18 years) presenting to ED with suspected infection

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.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age, suspected infection

Exclusion Criteria:

* None

Primary outcomes:
measure: Measurement of plasma levels of HBP to evaluate patients with suspected infection for their risk of developing severe sepsis
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: York
country: United States
facility: York Hospitals
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Drexel University
name: Theodore Corbin, MD
role: PRINCIPAL_INVESTIGATOR
References: