BNP Therapy Observation Unit Outcomes STudy (BOOST)
BOOST
2 other identifiers
interventional
17
1 country
1
Brief Summary
The investigators hypothesize that patients admitted to an emergency department (ED) observation unit will have a decreased rate of hospital admissions and ED recidivism when treated with nesiritide versus standard therapy. The investigators also hypothesize that decreasing B-type Natriuretic Peptide (BNP) levels during treatment in an ED observation unit will predict improved patient outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFebruary 9, 2015
February 1, 2015
6 months
March 28, 2007
February 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects that return to the emergency department in 90 days
90 days
Secondary Outcomes (1)
Correlation between BNP levels at admission and number of subjects who return to the emergency department
90 days
Study Arms (2)
Nesiritide
EXPERIMENTALSubjects who come into the ED with CHF will be treated with nesiritide
Standard care
NO INTERVENTIONSubjects who come into the ED with CHF will receive standard care treatment
Interventions
Eligibility Criteria
You may qualify if:
- Adult patient \> 18 years of age
- Alert, oriented and able to provide informed consent.
You may not qualify if:
- Dialysis Dependent Renal Failure
- Temperature \> 38.5 degrees celsius
- Pneumonia (Infiltrates on Chest X-ray)
- Requiring IV vasoactive agents (Other than Nesiritide)
- Killip Class III/IV
- Systolic blood pressure \< 90 mmHg
- EKG diagnostic or suggestive of Acute myocardial infarction or ischemia
- Abnormal Cardiac Markers
- Lack of a telephone
- Inability to provide informed consent due to cognitive impairment or a severe psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Scios, Inc.collaborator
Study Sites (1)
Grady Memorial Hosptial
Atlanta, Georgia, 30303, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Ander, MD
Emory University
- PRINCIPAL INVESTIGATOR
Daniel Wu, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 28, 2007
First Posted
March 29, 2007
Study Start
March 1, 2007
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
February 9, 2015
Record last verified: 2015-02