- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00587938
BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED
December 26, 2007 updated by: Mayo Clinic
BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED: A Clinical Development Project
Measurement of brain natriuretic peptide (BNP) in dyspneic patients increases diagnostic accuracy for congestive heart failure (CHF).
Limited information is available regarding economic outcomes attributable to BNP assay.
The aim of this study was to assess the economic impact of BNP assay in elderly dyspneic patients presenting to the emergency department (ED).
Study Overview
Status
Completed
Conditions
Detailed Description
Dyspneic patients 65 years were enrolled in a randomized, controlled trial; hemodynamically unstable patients were excluded.
BNP (Biosite assay) levels were measured prior to physician assessment with randomization in 1:1 ratio to either BNP 1) level reported or 2) level not reported.
ED physicians made triage decisions guided by clinical judgment and nomogram to aid in interpretation of BNP level.
Primary outcome was mean total hospital cost per subject.
Secondary outcomes included admission rate, service assignment, discharge diagnosis and length of stay.
Differences between groups were compared by t-test with bootstrap.
Costs reflect 2005 constant dollars.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Saint Marys Hospital, Mayo Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Dyspneic patients:65 years or older presenting to the ED with chief complaint of shortness of breath, were enrolled in a randomized, controlled trial.
Description
Inclusion Criteria:
- Dyspneic patients 65 years or older presenting to the ED with chief complaint of shortness of breath.
Exclusion Criteria:
- hemodynamically unstability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
A
BNP level from protocol blood tests initiated in the ED, reported to ED physician prior to ED disposition.
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B
BNP level from protocol blood tests initiated in the ED, NOT reported to ED physician prior to ED disposition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Mean total hospital cost per subject
Time Frame: spans from ED eval through hospitalization discharge
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spans from ED eval through hospitalization discharge
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Included admission rate, service assignment, discharge diagnosis, and length of stay.
Time Frame: from ED evaluation through hospitalization discharge
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from ED evaluation through hospitalization discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raquel M Schears, MD, MPH, Mayo Clinic
- Principal Investigator: Alfredo L Clavell, MD, Mayo Clinic
- Study Chair: Lyle J Olsen, MD, Mayo Clinic
- Study Director: Paula J Santrach, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schmidt TA, Salo D, Hughes JA, Abbott JT, Geiderman JM, Johnson CX, McClure KB, McKay MP, Razzak JA, Schears RM, Solomon RC; SAEM Ethics Committee. Confronting the ethical challenges to informed consent in emergency medicine research. Acad Emerg Med. 2004 Oct;11(10):1082-9. doi: 10.1197/j.aem.2004.05.028.
- Clavell AL, Stingo AJ, Aarhus LL, Burnett JC Jr. Biological actions of brain natriuretic peptide in thoracic inferior vena caval constriction. Am J Physiol. 1993 Dec;265(6 Pt 2):R1416-22. doi: 10.1152/ajpregu.1993.265.6.R1416.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
March 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
December 26, 2007
First Posted (Estimate)
January 8, 2008
Study Record Updates
Last Update Posted (Estimate)
January 8, 2008
Last Update Submitted That Met QC Criteria
December 26, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1780-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.