Contact information
Type
Scientific
Primary contact
Dr J.H.W. Rutten
ORCID ID
Contact details
Erasmus Medical Centre
Rotterdam
3015 CE
Netherlands
+31 (0)10 4639222
j.rutten@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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 dyspnoea might improve care and reduce length of hospital stay. 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.
Ethics approval
Received from the Medical Ethics Review Comittee Erasmus MC on the 13th October 2004 (ref: MEC-2004-201).
Study design
Randomised, single blinded, controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Cost-effectiveness, dyspnoea, amino-terminal pro B-type natriuretic peptide
Intervention
Study-group:
Measurement of NT-proBNP plasma level at presentation in the Emergency Department.
Control-group:
No measurement of NT-proBNP plasma level at presentation in the Emergency Department. Blood was collected for determination of NT-proBNP levels at the end of the study.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Time to discharge, measured at discharge from hospital
2. Cost of treatment, measured at discharge from hospital
Secondary outcome measures
1. Duration of stay at the Emergency Department, measured at discharge from the Emergency Department
2. Proportion of patients admitted to the hospital, measured at discharge from hospital of last included subject, end of study
3. Proportion of patients admitted to an intensive or coronary care unit, measured at discharge from hospital of last included subject, end of study
4. Specialist consultations, measured at discharge from hospital of last included subject, end of study
5. Medical treatment, measured at discharge from hospital of last included subject, end of study
6. Diagnostic investigations, measured at discharge from hospital of last included subject, end of study
Overall trial start date
12/01/2004
Overall trial end date
05/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18 years or older
2. Acute dyspnoea as the most prominent complaint
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
477
Participant exclusion criteria
1. Acute dyspnoea due to a trauma
2. Acute dyspnoea due to cardiogenic shock
3. Renal failure requiring dialysis
Recruitment start date
12/01/2004
Recruitment end date
05/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3015 CE
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Internal Medicine
Rotterdam
3000 DR
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands) - Mrace Committee
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary