- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01392508
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
Status
Completed
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
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Linkoping, Sweden
- Universitetssjukhuset i Linköping
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Lund, Sweden
- Skanes Universitetssjukhus I Lund
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Malmo, Sweden
- Skanes Universitetssjukhuset i Malmo
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Orebro, Sweden
- Universitetssjukhuset I Orebro
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New Jersey
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Camden, New Jersey, United States
- Cooper University Hospital
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP-FMHBP-001
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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