Biomarker-enhanced ED Disposition Decisions

Non-specific Complaints Clinical Trial

— BANC4  

Official title:

BANC4 (BASEL NON - SPECIFIC COMPLAINTS 4) Biomarker-enhanced Disposition Decisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920491
• Other study ID #: ED UHBS
• Status: Completed
• Phase: N/A
• First received: June 12, 2009
• Last updated: December 12, 2014
• Start date: July 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Patients presenting to emergency departments (ED) with non-specific complaints (NSC) such as "not feeling well", "feeling weak", "being tired", "general deterioration" are a very common and well-known, but poorly studied patient group. The differential diagnosis of NSC is extremely broad ranging from insufficient home care to acute life-threatening conditions. Therefore, the evaluation and diagnostic work-up of these mostly elderly patients with NSC is very time-consuming and not straight-forward. Furthermore, the assessment is complicated by comorbidities, polypharmacy or an altered mental status. For this reason, potentially unnecessary diagnostic efforts are undertaken in order to exclude a serious underlying condition, leading to prolonged throughput times and ED observation unit stays.

On the other hand, the patients` condition might be underestimated by ED physicians, which may result in ineffective, delayed or inadequate disposition, as well as poor patient outcomes. BANC (formerly BAUCAS) is a series of clinical studies with the intention to investigate the usefulness of clinical findings and biomarker levels combined for disposition of patients with non-specific complaints presenting to the emergency department.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult non-trauma patients with an Emergency Severity Index (ESI) of 2 or 3 are screened for inclusion

Exclusion Criteria:

• patients with specific chief complaints are excluded. Moreover, patients in whom an unambiguous and clear working hypothesis with logical management steps can be established are excluded

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Non-specific Complaints

Intervention

Biological:
• biomarker-enhanced disposition decision with proADM
To compare the outcome of standard of care with an approach combining the standardized course and biomarker levels (biomarker-enhanced disposition decision with proADM) for the disposition of patients with non-specific complaints presenting to the emergency department (ED), in order to evaluate safety.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration)		30 days	No
Secondary	30 day mortality		30 days	No