Help in the Emergency Room to Detect Organ Dysfunction

• Conditions: Sepsis; Critical Illness

• Registration Number: NCT02366650
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-19
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-21
• Primary Completion: 2016-03
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers	72 hours
• number of days of antibiotics , time to effective antibiotics	72 hrs
• 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
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

Trial Locations

Locations (4)

Lund ED; 🇸🇪 Lund, Sweden

John Boyd; 🇨🇦 Vancouver, Canada

Helsingborg; 🇸🇪 Helsingborg, Sweden

Bern ED; 🇨🇭 Bern, Switzerland