Sepsis Assessment in Belgian Emergency Rooms

NCT ID: NCT02424721

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-12-31

Brief Summary

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To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.

Detailed Description

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Prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected infection following emergency department admission.

Patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken.

The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF. The enrolment sample will then be retrospectively measured for the HBP level and the power of the enrolment HBP level to predict subsequent clinical development over the following 72 hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the HBP level to predict the final clinical outcome.

Conditions

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Sepsis Shock, Septic Severe Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* \>18 years of age,
* Suspected infection (temperature \>38C or clinical evidence of infection),
* intention by clinician to start antibiotics

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axis Shield Diagnostics Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis Vincent, MD

Role: PRINCIPAL_INVESTIGATOR

Erasme University Hospital

Locations

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Clinique St Anne St Remy

Anderlecht, , Belgium

Site Status

Hopital Erasme

Brussels, , Belgium

Site Status

Hopital Civil de Charleroi

Charleroi, , Belgium

Site Status

CHU Tivoli

La Louvière, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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PEP-FMHBP-003

Identifier Type: -

Identifier Source: org_study_id

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