Back to resultsNT-proBNP in Acute Dyspnea: Effects on Treatment, Hospitalisation and Costs
Primary Purpose
Heart Failure, Dyspnea
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
NT-proBNP testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Heart failure, Diagnostic, Natriuretic peptide, NT-pro B-type natriuretic peptide, Length of stay, Costs
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Acute dyspnea as their most prominent complaint
Exclusion Criteria:
- Acute dyspnea due to a trauma
- Acute dyspnea due to cardiogenic shock
- Renal failure requiring dialysis
Sites / Locations
- Erasmus MC
Outcomes
Primary Outcome Measures
Time to discharge
Cost of treatment
Secondary Outcome Measures
Duration of stay at the ED
Proportion of patients admitted to the hospital
Proportion of patients admitted to an intensive or coronary care unit
Specialist consultations
Medical treatment
Diagnostic investigations
Full Information
NCT ID
NCT00410293
First Posted
December 11, 2006
Last Updated
December 11, 2006
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00410293
Brief Title
NT-proBNP in Acute Dyspnea: Effects on Treatment, Hospitalisation and Costs
Official Title
NT-proBNP Testing in Patients Presenting to the Emergency Department With Acute Dyspnea: Evaluation of Effects on Treatment, Hospitalisation Rate and Costs
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Erasmus Medical Center
4. Oversight
5. Study Description
Brief Summary
Diagnostic uncertainty in patients with complaints of shortness of breath presenting to the Emergency Department of a hospital may delay treatment and proper care. In patients with shortness of breath due to heart failure increased plasma levels of NT-pro-B-type natriuretic peptide (NT-proBNP) can be demonstrated. The use of NT-proBNP as a biomarker for heart failure in patients presenting to the emergency department with dyspnea might improve care and reduce length of hospital stay.
To investigate the effect of NT-proBNP testing on patient care and time to discharge the NT-proBNP test will be randomized. In patients in the study group, the NT-proBNP plasma level is determined at admission and the physician in charge will immediately receive the result of the test. In patients in the control group blood will be sampled but the physician will recieve no information on the NT-proBNP plasma level.
In our study we will investigate the effect of introduction of NT-proBNP as biomarker for heart failure on treatment, time to discharge and costs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Dyspnea
Keywords
Heart failure, Diagnostic, Natriuretic peptide, NT-pro B-type natriuretic peptide, Length of stay, Costs
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
NT-proBNP testing
Primary Outcome Measure Information:
Title
Time to discharge
Title
Cost of treatment
Secondary Outcome Measure Information:
Title
Duration of stay at the ED
Title
Proportion of patients admitted to the hospital
Title
Proportion of patients admitted to an intensive or coronary care unit
Title
Specialist consultations
Title
Medical treatment
Title
Diagnostic investigations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Acute dyspnea as their most prominent complaint
Exclusion Criteria:
Acute dyspnea due to a trauma
Acute dyspnea due to cardiogenic shock
Renal failure requiring dialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton H. van den Meiracker, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
NT-proBNP in Acute Dyspnea: Effects on Treatment, Hospitalisation and Costs
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