Condition category
Respiratory
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
12/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/content/englishindex.htm

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

Publication citations

Additional files

Editorial Notes