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

Congestive Heart Failure Clinical Trial

Official title:

BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED: A Clinical Development Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587938
• Other study ID #: 1780-03
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: December 26, 2007
• Start date: December 2003
• Est. completion date: March 2005

Study information

• Verified date: December 2007
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• hemodynamically unstability

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	Saint Marys Hospital, Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean total hospital cost per subject		spans from ED eval through hospitalization discharge	No
Secondary	Included admission rate, service assignment, discharge diagnosis, and length of stay.		from ED evaluation through hospitalization discharge	No

External Links

•   Mayo Clinic Clinical Trials