N-terminal pro-B-type natriuretic peptide testing in patients presenting to the Emergency Department With acute dyspnoea: evaluation of effects on treatment, hospitalisation rate and costs

ISRCTN ISRCTN28653133
DOI https://doi.org/10.1186/ISRCTN28653133
Protocol serial number NL931 (NTR956)
Sponsor Erasmus Medical Centre (The Netherlands)
Funder Erasmus Medical Centre (The Netherlands) - Mrace Committee
Submission date
30/05/2007
Registration date
30/05/2007
Last edited
25/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J.H.W. Rutten
Scientific

Erasmus Medical Centre
Rotterdam
3015 CE
Netherlands

Phone +31 (0)10 4639222
Email j.rutten@erasmusmc.nl

Study information

Primary study designInterventional
Study designRandomised, single blinded, controlled, parallel group trial
Secondary study designRandomised controlled trial
Scientific titleN-terminal pro-B-type natriuretic peptide testing in patients presenting to the Emergency Department With acute dyspnoea: evaluation of effects on treatment, hospitalisation rate and costs
Study objectivesDiagnostic 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(s)Received from the Medical Ethics Review Comittee Erasmus MC on the 13th October 2004 (ref: MEC-2004-201).
Health condition(s) or problem(s) studiedCost-effectiveness, dyspnoea, amino-terminal pro B-type natriuretic peptide
InterventionStudy-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 typeOther
Primary outcome measure(s)

1. Time to discharge, measured at discharge from hospital
2. Cost of treatment, measured at discharge from hospital

Key secondary outcome measure(s)

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

Completion date05/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target sample size at registration477
Key inclusion criteria1. Age 18 years or older
2. Acute dyspnoea as the most prominent complaint
Key exclusion criteria1. Acute dyspnoea due to a trauma
2. Acute dyspnoea due to cardiogenic shock
3. Renal failure requiring dialysis
Date of first enrolment12/01/2004
Date of final enrolment05/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre
Rotterdam
3015 CE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/07/2008 25/10/2021 Yes No

Editorial Notes

25/10/2021: Publication reference added.