BANC4: Biomarker-enhanced ED Disposition Decisions

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT00920491
Collaborator
(none)
400
1
36
11.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: biomarker-enhanced disposition decision with proADM

Study Design

Study Type:
Observational
Actual Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
BANC4 (BASEL NON - SPECIFIC COMPLAINTS 4) Biomarker-enhanced Disposition Decisions
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration) [30 days]

Secondary Outcome Measures

  1. 30 day mortality [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Basel Basel Switzerland 4031

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00920491
Other Study ID Numbers:
  • ED UHBS
First Posted:
Jun 15, 2009
Last Update Posted:
Dec 15, 2014
Last Verified:
Dec 1, 2014

Study Results

No Results Posted as of Dec 15, 2014