跳至主要内容
临床试验/NCT02003040
NCT02003040Unknown不适用

Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions

Mespere Lifesciences Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Change from baseline in non-invasive central venous pressure (NICVP) at time of hospital discharge

研究概览

简要总结

The purpose of this study is to investigate the utility of Venus 1000 in predicting 30-day hospital readmissions for acute decompensated heart failure. Secondary outcomes will include correlation with NT-proBNP and weight both at admission and discharge from hospital

详细描述

Rehospitalizations for heart failure have been linked to poor clinical outcomes, rates remain high despite different attempts to decrease them . Clinical indicators of volume congestion at time of discharge are associated with increased rates of readmission . Clinical evaluation of volume status remains the gold standard in determination of readiness and timing of hospital discharge, however identification of persistent congestion might prove difficult .

Assessment of the right atrial pressure can be done non-invasively at the bedside; however, precision and accuracy of this method are variable . Echocardiography is a valuable tool in the estimation of elevated central pressure , this, however is time consuming and requires trained personnel. While invasive measurements provide accurate estimation of central venous pressure, it is an impractical approach in most patients, notwithstanding the risks associated with the insertion of a catheter into the central circulation .

Since a significant proportion of readmitted patients return to hospital with congestive symptoms, attempts have been made to improve our ability to assess volume status . Current clinical evidence suggests that BNP-guided management of patients with congestive heart failure can decrease all-cause mortality and heart failure rehospitalization. However, biological variation for natriuretic peptides is high , and optimal targets are difficult to determine in individual patients.

The Mespere Venus 1000 system is a non-invasive tool that has previously shown reliable correlation and accuracy with central venous pressure obtained invasively in the catheterization laboratory and good correlation with jugular venous pressure at the bedside.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 admitted to St. Michael's Hospital with a main clinical diagnosis of decompensated heart failure.
  • Signed informed consent

排除标准

  • Lack of patient consent.
  • Presence of known AV dialysis fistula.
  • Allergy to adhesive tape from Mespere Venus 1000 system.
  • Known central vein stenosis.
  • Ongoing photodynamic therapy.
  • Assisted ventilation.
  • Associated acute coronary syndrome

结局指标

主要结局

Change from baseline in non-invasive central venous pressure (NICVP) at time of hospital discharge

时间窗: time of hospital admission (baseline) and time of hospital discharge

To determine if NICVP (taken at time of hospital admission and discharge) from the Mespere Venus 1000 CVP System can predict 30-day hospital readmissions for acute decompensated heart failure.

次要结局

  • NT-proBNP(1 visit)
  • Patient's weight(1 visit)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Role of the Mespere Venus 1000 in Predicting Heart... | 临床试验