Help in the Emergency Room to Detect Organ Dysfunction

NCT ID: NCT02366650

Last Updated: 2015-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Sepsis Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lund ED

appr 100-200 patients at Lund ED

No interventions assigned to this group

Helsingborg ED

appr 100-200 patients at Helsingborg ED

No interventions assigned to this group

Vancouver ED

appr 100 patients at St Paul's hospital ED

No interventions assigned to this group

Bern ED

appr 100 patients at Bern ED

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Adam Linder

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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John Boyd

Vancouver, , Canada

Site Status COMPLETED

Helsingborg

Helsingborg, , Sweden

Site Status RECRUITING

Lund ED

Lund, , Sweden

Site Status RECRUITING

Bern ED

Bern, , Switzerland

Site Status COMPLETED

Countries

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Canada Sweden Switzerland

Facility Contacts

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Jonas Tverring

Role: primary

Adam Linder

Role: primary

Other Identifiers

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HERO1

Identifier Type: -

Identifier Source: org_study_id

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