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

April 13, 2017 updated by: Axis Shield Diagnostics Ltd

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.

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

759

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Linkoping, Sweden
        • Universitetssjukhuset i Linköping
      • Lund, Sweden
        • Skanes Universitetssjukhus I Lund
      • Malmo, Sweden
        • Skanes Universitetssjukhuset i Malmo
      • Orebro, Sweden
        • Universitetssjukhuset I Orebro
    • New Jersey
      • Camden, New Jersey, United States
        • Cooper University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting to emergency department with suspected infection

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Adam Linder, Skanes Universitetssjukhus I Lund, Sweden
  • Principal Investigator: Magnus Paulsson, Skanes Universitetssjukhuset i Malmo
  • Principal Investigator: Patrik Nyberg, Universitetssjukhuset i Linköping
  • Principal Investigator: Anna Lange-Jendeberg, Universitetssjukhuset I Orebro
  • Principal Investigator: Ryan Arnold, The Cooper Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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