Biomarker-enhanced ED Disposition Decisions (BANC4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00920491
First received: June 12, 2009
Last updated: December 12, 2014
Last verified: December 2014
  Purpose

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 Intervention
Non-specific Complaints
Biological: biomarker-enhanced disposition decision with proADM

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: BANC4 (BASEL NON - SPECIFIC COMPLAINTS 4) Biomarker-enhanced Disposition Decisions

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
whole blood (MR-proADM)

Enrollment: 400
Study Start Date: July 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920491

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Roland Bingisser, MD University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00920491     History of Changes
Other Study ID Numbers: ED UHBS 
Study First Received: June 12, 2009
Last Updated: December 12, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Chief complaint
non-specific symptoms
general weakness / general deterioration
risk assessment in ED patients with non-specific symptoms

ClinicalTrials.gov processed this record on July 25, 2016