Non-specific ComplaintsBANC4NCT00920491
Biomarker-enhanced ED Disposition Decisions
An observational study of Non-specific Complaints, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-specific Complaints
- What is being tested?
- biomarker-enhanced disposition decision with proADM
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All adult non-trauma patients with an Emergency Severity Index (ESI) of 2 or 3 are screened for inclusion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Non-specific Complaints
- Being tested
- biomarker-enhanced disposition decision with proADM
- Keywords
- Chief complaint, non-specific symptoms, general weakness / general deterioration, risk assessment in ED patients with non-specific symptoms
- Medical subject headings
- Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarker-enhanced disposition decision with proADMBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with non-specific complaints | patients who do not have specific presenting symptoms (e.g. dyspnea, chest pain etc.) Receives: Biological: biomarker-enhanced disposition decision with proADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration)
Measured: 30 days
Secondary outcomes (1)
30 day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non-specific ComplaintsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Bingisser, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920491
- Sponsor's protocol ID
- ED UHBS
- Acronym
- BANC4
- Status last verified
- Dec 2014
- First submitted
- 12 Jun 2009
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 27053291Nickel 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.
PubMed 26735540Karakoumis 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.
PubMed 26131835Peng 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.
PubMed 25741894Nickel 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.
PubMed 23497667Ruedinger 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.
PubMed 22573483
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BANC4 (BASEL NON - SPECIFIC COMPLAINTS 4) Biomarker-enhanced Disposition Decisions
- ClinicalTrials.gov ID
- NCT00920491
- Acronym / sponsor ID
- BANC4 / ED UHBS
- Conditions
- Non-specific Complaints
- Keywords
- Chief complaint, non-specific symptoms, general weakness / general deterioration, risk assessment in ED patients with non-specific symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with non-specific complaints | – | Biological: biomarker-enhanced disposition decision with proADMpatients who do not have specific presenting symptoms (e.g. dyspnea, chest pain etc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All adult non-trauma patients with an Emergency Severity Index (ESI) of 2 or 3 are screened for inclusion
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biomarker-enhanced disposition decision with proADMTo 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. | Biological | patients with non-specific complaints |
Primary outcome
serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration)
Time frame: 30 days
1 secondary outcome
30 day mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- Derived from this study: PubMed 27053291Nickel 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.
- Derived from this study: PubMed 26735540Nickel 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.
- Derived from this study: PubMed 26131835Karakoumis 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.
- Derived from this study: PubMed 25741894Peng 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.
- Derived from this study: PubMed 23497667Nickel 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.
- Derived from this study: PubMed 22573483Ruedinger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Bingisser, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-specific Complaints, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00920491, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2014.