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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587938
First received: December 26, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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
Congestive Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean total hospital cost per subject [ Time Frame: spans from ED eval through hospitalization discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Included admission rate, service assignment, discharge diagnosis, and length of stay. [ Time Frame: from ED evaluation through hospitalization discharge ] [ Designated as safety issue: No ]

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.


Enrollment: 200
Study Start Date: December 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: December 26, 2007
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014