Help in the Emergency Room to Detect Organ Dysfunction

Sepsis Clinical Trial

— HERO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02366650
• Other study ID #: HERO1
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2015
• Last updated: October 19, 2015
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2015
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Region Skåne Sweden ':'
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Sepsis

Locations

Country	Name	City	State
Canada	John Boyd	Vancouver
Sweden	Helsingborg	Helsingborg
Sweden	Lund ED	Lund
Switzerland	Bern ED	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Countries where clinical trial is conducted

Canada,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers		72 hours	No
Secondary	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	No
Secondary	To investigate and identify risk factors for a negative long-term (5-10 year) outcome.		10 years	No
Secondary	• Organ dysfunction 24-36 and 72 hours after arriving at the hospital		72 hrs	No
Secondary	• Primary diagnosis infection (y/n)		72 hrs	No
Secondary	• number of days on ward and ICU		90 days	No
Secondary	• number of days of antibiotics , time to effective antibiotics		72 hrs	No