IMproved PREdiction of Severe Sepsis in the Emergency Department (IMPRESSED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01392508
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Axis Shield Diagnostics Ltd

Brief 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.

Condition or disease
Systemic Inflammatory Response Syndrome (SIRS) Sepsis Severe Sepsis Septic Shock

Study Type : Observational
Actual Enrollment : 759 participants
Observational Model: Case-Only
Time Perspective: Prospective
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.
Study Start Date : March 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Biospecimen Retention:   Samples With DNA
Plasma (LiHep and citrate)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to emergency department with suspected infection

Inclusion Criteria:

  • Greater than or equal to 18 years
  • Suspected Infection
  • one or more SIRS criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01392508

United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States
Universitetssjukhuset i Linkoping
Linkoping, Sweden
Skanes Universitetssjukhus i Lund
Lund, Sweden
Skanes Universitetssjukhuset i Malmo
Malmo, Sweden
Universitetssjukhuset i Orebro
Orebro, Sweden
Sponsors and Collaborators
Axis Shield Diagnostics Ltd
Principal Investigator: Adam Linder Skanes Universitetssjukhus I Lund, Sweden
Principal Investigator: Magnus Paulsson Skanes universitetssjukhuset i Malmo
Principal Investigator: Patrik Nyberg Universitetssjukhuset i Linkoping
Principal Investigator: Anna Lange-Jendeberg Universitetssjukhuset i Orebro
Principal Investigator: Ryan Arnold The Cooper Health System

Publications of Results:
Responsible Party: Axis Shield Diagnostics Ltd Identifier: NCT01392508     History of Changes
Other Study ID Numbers: PEP-FMHBP-001
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Disease Attributes
Pathologic Processes