IMproved PREdiction of Severe Sepsis in the Emergency Department

Sepsis Clinical Trial

— IMPRESSED  

Official title:

Prospective, Non-interventional, Multi-centre Clinical Study 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392508
• Other study ID #: PEP-FMHBP-001
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: April 13, 2017
• Start date: March 2011
• Est. completion date: September 2015

Study information

• Verified date: April 2017
• Source: Axis Shield Diagnostics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Greater than or equal to 18 years

• Suspected Infection

• one or more SIRS criteria

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Systemic Inflammatory Response Syndrome
• Systemic Inflammatory Response Syndrome (SIRS)
• Toxemia

Locations

Country	Name	City	State
Sweden	Universitetssjukhuset i Linkoping	Linkoping
Sweden	Skanes Universitetssjukhus i Lund	Lund
Sweden	Skanes Universitetssjukhuset i Malmo	Malmo
Sweden	Universitetssjukhuset i Orebro	Orebro
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Axis Shield Diagnostics Ltd

Countries where clinical trial is conducted

United States,  Sweden, 

References & Publications (1)

Linder A, Arnold R, Boyd JH, Zindovic M, Zindovic I, Lange A, Paulsson M, Nyberg P, Russell JA, Pritchard D, Christensson B, Åkesson P. Heparin-Binding Protein Measurement Improves the Prediction of Severe Infection With Organ Dysfunction in the Emergency — View Citation