NT-proBNP in Acute Dyspnea: Effects on Treatment, Hospita... | NCT00410293

Studies
NT-proBNP in Acute Dyspnea: Effects on Treatment, Hospitalisation and Costs

NCT00410293

Sponsor

Erasmus Medical Center

Status

Completed

Last Update Posted

Dec 12, 2006Estimated

Enrollment

500

Phase

Not Applicable

Conditions

Heart Failure
Dyspnea

Interventions

NT-proBNP testing

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Aug 2006

First Submitted Date

Dec 11, 2006

First Submission Date that Met QC Criteria

Dec 11, 2006

First Posted Date

Dec 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2006

Last Update Posted Date

Dec 12, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500

Name	Type	Description	Arm Group Labels	Other Names
NT-proBNP testing	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to discharge
Cost of treatment

Secondary Outcomes

Measure	Description	Time Frame
Duration of stay at the ED
Proportion of patients admitted to the hospital
Proportion of patients admitted to an intensive or coronary care unit

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anton H. van den Meiracker, MD, PhD	Erasmus Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus MC		Rotterdam		3015 CE	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D004417	Dyspnea
D004194	Disease

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided