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BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED

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ClinicalTrials.gov Identifier: NCT00587938
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : January 8, 2008
Sponsor:
Information provided by:
Mayo Clinic

Brief Summary:
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).

Condition or disease
Congestive Heart Failure

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
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED: A Clinical Development Project
Study Start Date : December 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
A
BNP level from protocol blood tests initiated in the ED, reported to ED physician prior to ED disposition.
B
BNP level from protocol blood tests initiated in the ED, NOT reported to ED physician prior to ED disposition.



Primary Outcome Measures :
  1. Mean total hospital cost per subject [ Time Frame: spans from ED eval through hospitalization discharge ]

Secondary Outcome Measures :
  1. Included admission rate, service assignment, discharge diagnosis, and length of stay. [ Time Frame: from ED evaluation through hospitalization discharge ]

Biospecimen Retention:   Samples Without DNA
Original protocol specifies a single 10 ml of blood is collected and frozen from each study participant (N=200), to be available for research assays.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Dyspneic patients 65 years or older presenting to the ED with chief complaint of shortness of breath.

Exclusion Criteria:

  • hemodynamically unstability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587938


Locations
United States, Minnesota
Saint Marys Hospital, Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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

Additional Information:
Publications:
Responsible Party: Dr Raquel Marie Schears MD, MPH, FACEP (Co-PI), Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587938     History of Changes
Other Study ID Numbers: 1780-03
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: December 2007

Keywords provided by Mayo Clinic:
congestive heart failure
Brain naturietic peptide
hospital utilization cost

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases