Biomarker-enhanced ED Disposition Decisions

NCT00920491 | Completed DMC

• 1 other identifier: ED UHBS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-specific Complaints

Keywords

Chief complaint; non-specific symptoms; general weakness / general deterioration; risk assessment in ED patients with non-specific symptoms

Outcome Measures

Primary Outcomes (1)

• serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration)

  30 days

Secondary Outcomes (1)

• 30 day mortality

  30 days

Study Arms (1)

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

Interventions

biomarker-enhanced disposition decision with proADM BIOLOGICAL

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.

patients with non-specific complaints

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 27053291 DERIVED

• 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.

  PMID: 26735540 DERIVED

• 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.

  PMID: 26131835 DERIVED

• 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.

  PMID: 25741894 DERIVED

• 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.

  PMID: 23497667 DERIVED

• 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.

  PMID: 22573483 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood (MR-proADM)

MeSH Terms

Conditions

Asthenia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland Bingisser, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

CH (1)