Clinical trial NCT00587938: BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED
Official title: BNP Measurement Reduces Resource Utilization for Patients With CHF Admitted Thorough the ED: A Clinical Development Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Keywords: congestive heart failure
Brain naturietic peptide
hospital utilization cost
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* hemodynamically unstability

Primary outcomes:
measure: Mean total hospital cost per subject
timeFrame: spans from ED eval through hospitalization discharge
Secondary outcomes:
measure: Included admission rate, service assignment, discharge diagnosis, and length of stay.
timeFrame: from ED evaluation through hospitalization discharge
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Saint Marys Hospital, Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Raquel M Schears, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Alfredo L Clavell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Lyle J Olsen, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Paula J Santrach, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1197/j.aem.2004.05.028.
citation: 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.