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ClinicalTrials.gov ID

NCT02366650

Lead Sponsor

Region SkaneOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

600Estimated

Last Update Posted

Oct 21, 2015Estimated

Start Date

Feb 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Aug 2016Estimated

Official Title

Help in the Emergency Room to Detect Organ Dysfunction - The HERO Study

Brief Summary

The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. Secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Heparin Binding Protein in human plasma.

• Sepsis
• Critical Illness

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

i) ≥18 years of age ii) 1 or more of the following criteria: Saturation<90% without oxygen or <93% with oxygen or reported saturation<90%, Respiratory frequency >25/min, Altered mental awareness, Heart rate >120/min, Systolic blood pressure <100 mm Hg. iv) informed consent.

Exclusion Criteria:

None

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Region SkaneOTHER

adam.linder@med.lu.se