Biomarker-enhanced ED Disposition Decisions

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-specific Complaints

Intervention / Treatment
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* Biological: biomarker-enhanced disposition decision with proADM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with non-specific complaints<br>patients who do not have specific presenting symptoms (e.g. dyspnea, chest pain etc.) | Biological: biomarker-enhanced disposition decision with proADM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration) |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day mortality |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chief complaint, non-specific symptoms, general weakness / general deterioration, risk assessment in ED patients with non-specific symptoms