Biomarker-enhanced ED Disposition Decisions (BANC4)

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

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.

Study Overview

• Status: Completed
• Conditions: Non-specific Complaints
• Intervention / Treatment: Biological: biomarker-enhanced disposition decision with proADM

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The protocol of the BANC study specifies that patients are consecutively enrolled in order to obtain a random sample of the source population of ED self-referred and referred patients with UC

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with non-specific complaints; patients who do not have specific presenting symptoms (e.g. dyspnea, chest pain etc.)	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
30 day mortality	30 days

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Roland Bingisser, MD, University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• Nickel CH, Kuster T, Keil C, Messmer AS, Geigy N, Bingisser R. Risk stratification using D-dimers in patients presenting to the emergency department with nonspecific complaints. Eur J Intern Med. 2016 Jun;31:20-4. doi: 10.1016/j.ejim.2016.03.006. Epub 2016 Apr 1.
• Nickel CH, Messmer AS, Ghanim L, Ilsemann-Karakoumis J, Giersdorf S, Hertel S, Ernst S, Geigy N, Bingisser R. Adrenomedullin for Risk Stratification of Emergency Patients With Nonspecific Complaints: An Interventional Multicenter Pilot Study. Medicine (Baltimore). 2016 Jan;95(1):e2395. doi: 10.1097/MD.0000000000002395.
• Karakoumis J, Nickel CH, Kirsch M, Rohacek M, Geigy N, Muller B, Ackermann S, Bingisser R. Emergency Presentations With Nonspecific Complaints-the Burden of Morbidity and the Spectrum of Underlying Disease: Nonspecific Complaints and Underlying Disease. Medicine (Baltimore). 2015 Jul;94(26):e840. doi: 10.1097/MD.0000000000000840.
• Peng A, Rohacek M, Ackermann S, Ilsemann-Karakoumis J, Ghanim L, Messmer AS, Misch F, Nickel CH, Bingisser R. The proportion of correct diagnoses is low in emergency patients with nonspecific complaints presenting to the emergency department. Swiss Med Wkly. 2015 Mar 5;145:w14121. doi: 10.4414/smw.2015.14121. eCollection 2015.
• Nickel CH, Ruedinger JM, Messmer AS, Maile S, Peng A, Bodmer M, Kressig RW, Kraehenbuehl S, Bingisser R. Drug-related emergency department visits by elderly patients presenting with non-specific complaints. Scand J Trauma Resusc Emerg Med. 2013 Mar 5;21:15. doi: 10.1186/1757-7241-21-15.
• Ruedinger JM, Nickel CH, Maile S, Bodmer M, Kressig RW, Bingisser R. Diuretic use, RAAS blockade and morbidity in elderly patients presenting to the Emergency Department with non-specific complaints. Swiss Med Wkly. 2012 May 9;142:w13568. doi: 10.4414/smw.2012.13568. eCollection 2012.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Estimate): December 15, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Chief complaint; non-specific symptoms; general weakness / general deterioration; risk assessment in ED patients with non-specific symptoms
• Other Study ID Numbers: ED UHBS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No