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临床试验/NCT00206843
NCT00206843已完成不适用

Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT II)

Abbott RDx Cardiometabolic20 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2004年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
630
试验地点
20
主要终点
Length of hospital stay

研究概览

简要总结

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 and/or during their admission. This is believed to lead to a better outcome as well as more efficient and cost-effective treatment.

详细描述

This is a patient-randomized clinical study consisting of patients who present to the ED requiring treatment and/or 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 testing.A 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and older Patient needs treatment for HF

排除标准

  • Current MI or ACS with ST deviation of 1 mm or greater Renal failure requiring dialysis Undergone hemodialysis within the last month Enrollment (Baseline) Triage® BNP concentration = 100 pg/ml or less Enrolled in any other drug trial or receiving an experimental treatment for HF.

结局指标

主要结局

Length of hospital stay

Combined cardiac related re-hospitalizations and all cause mortality (14-day and 30-day)

次要结局

  • Discharge BNP
  • Quality of life
  • Change in BNP from enrollment to discharge (ΔBNP)
  • Ratio of ΔBNP/length of stay
  • Cost Effectiveness

研究者

发起方
Abbott RDx Cardiometabolic
申办方类型
Other
责任方
Sponsor

研究点 (20)

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