Help in the Emergency Room to Detect Organ Dysfunction

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02366650

Acronym

HERO

Enrollment

600

Registered

2015-02-19

Start date

2015-02-28

Completion date

2016-08-31

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Sepsis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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
To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers	72 hours
• number of days on ward and ICU	90 days
• number of days of antibiotics , time to effective antibiotics	72 hrs
• Primary diagnosis infection (y/n)	72 hrs

Countries

Canada, Sweden, Switzerland

Outcome results