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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Basel, Sveits, 4031
- University Hospital Basel
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
patients with non-specific complaints
patients who do not have specific presenting symptoms (e.g.
dyspnea, chest pain etc.)
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration)
Tidsramme: 30 days
|
30 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
30 dagers dødelighet
Tidsramme: 30 dager
|
30 dager
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Roland Bingisser, MD, University Hospital, Basel, Switzerland
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ED UHBS
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .