Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206843
Status:
COMPLETED
Last Update Posted:
2015-07-27
First Post:
2005-09-12
Brief Title:
Rapid Emergency Department Heart Failure Outpatient Trial REDHOT II
Sponsor:
Abbott RDx Cardiometabolic
Organization:
Abbott RDx Cardiometabolic
Study Overview
Official Title:
Rapid Emergency Department Heart Failure Outpatient Trial REDHOT II
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test whether physicians can make more informed treatment admission and discharge decisions related to patient care by having serial Triage BNP test results available to assess disease severity while patients are being treated for HF in the Emergency Department andor during their admission This is believed to lead to a better outcome as well as more efficient and cost-effective treatment
Detailed Description:
This is a patient-randomized clinical study consisting of patients who present to the ED requiring treatment andor admission for HF At each site patients will be randomized into either a control arm or an experimental arm Serial blood samples will be collected from all patients throughout their stay in the ED and the hospital In the experimental arm the Triage BNP test will be performed on all blood samples collected and each BNP result will be made available to the attending physicians immediately In the control arm blood samples will not be analyzed on-site for BNP but instead sent directly to Biosite Inc for testingA comparison will be made between the control and experimental arms of the study to determine if there are any significant differences in length of stay re-hospitalizations all cause mortality BNP levels quality of life and costs to treat patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None