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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00410293
Other study ID # MEC-2004-201
Secondary ID
Status Completed
Phase N/A
First received December 11, 2006
Last updated December 11, 2006
Start date December 2004
Est. completion date August 2006

Study information

Verified date December 2006
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
NT-proBNP testing


Locations

Country Name City State
Netherlands Erasmus MC Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to discharge
Primary Cost of treatment
Secondary Duration of stay at the ED
Secondary Proportion of patients admitted to the hospital
Secondary Proportion of patients admitted to an intensive or coronary care unit
Secondary Specialist consultations
Secondary Medical treatment
Secondary Diagnostic investigations
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