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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Axis Shield Diagnostics Ltd
ClinicalTrials.gov Identifier:
NCT01392508
First received: July 11, 2011
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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
Systemic Inflammatory Response Syndrome (SIRS)
Sepsis
Severe Sepsis
Septic Shock

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Axis Shield Diagnostics Ltd:

Biospecimen Retention:   Samples With DNA

Plasma (LiHep and citrate)


Estimated Enrollment: 1000
Study Start Date: March 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting to emergency department with suspected infection

Criteria

Inclusion Criteria:

  • Greater than or equal to 18 years
  • Suspected Infection
  • one or more SIRS criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392508

Locations
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States
Sweden
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
Investigators
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
  More Information

No publications provided

Responsible Party: Axis Shield Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT01392508     History of Changes
Other Study ID Numbers: PEP-FMHBP-001
Study First Received: July 11, 2011
Last Updated: October 25, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Emergencies
Sepsis
Toxemia
Shock
Shock, Septic
Systemic Inflammatory Response Syndrome
Disease Attributes
Pathologic Processes
Infection
Inflammation

ClinicalTrials.gov processed this record on July 31, 2014