Help in the Emergency Room to Detect Organ Dysfunction (HERO)

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Critical Illness

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada
    • Completed
    • John Boyd
• Sweden
  • Helsingborg, Sweden
    • Recruiting
    • Helsingborg
    • Contact: Jonas Tverring; Email: jonas@tverring.com
  • Lund, Sweden
    • Recruiting
    • Lund ED
    • Contact: Adam Linder; Email: adam.linder@med.lu.se
• Switzerland
  • Bern, Switzerland
    • Completed
    • Bern ED

Participation Criteria

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

Subject enrolment will be based on adult patients presenting to the emergency department at the different sites with suspicion of organ dysfunction or identified at the hospital wars/units.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Lund ED; appr 100-200 patients at Lund ED
Helsingborg ED; appr 100-200 patients at Helsingborg ED
Vancouver ED; appr 100 patients at St Paul's hospital ED
Bern ED; appr 100 patients at Bern ED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infection-induced organ dysfunction	To evaluate the presence or development of infection-induced organ dysfunction within a 72 hour time period from enrolment at the Emergency Department.	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers	72 hours
To investigate the specificity, sensitivity and accuracy in biochemical markers to predict mortality, ICU-care, days in hospital and the persistence of organ dysfunction.	90 days
To investigate and identify risk factors for a negative long-term (5-10 year) outcome.	10 years
• Organ dysfunction 24-36 and 72 hours after arriving at the hospital	72 hrs
• Primary diagnosis infection (y/n)	72 hrs
• number of days on ward and ICU	90 days
• number of days of antibiotics , time to effective antibiotics	72 hrs

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Critical Illness
• Other Study ID Numbers: HERO1