Reducing the Length of Stay and Incidence of Rehospitalization in Heart Failure Patients by Measuring Peripheral Venous Pressure; a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
The purpose of the study is to determine if there is a reduction in the length of stay and rates of rehospitalization for patients diagnosed with congestive heart failure when physicians are provided daily measurements of peripheral venous pressure versus no daily measurements of peripheral venous pressure.
详细描述
The objective of the study is to evaluate the effectiveness of standard clinical care versus standard clinical care directed by peripheral venous pressure on length of hospital stay and incidence of rehospitalization among heart failure patients.
The study team hypothesizes that compared to standard clinical care the peripheral venous pressure-guided therapy is associated with shorter hospital stay and lesser incidence of 30-day rehospitalization. The study team will also collect data to determine if peripheral venous pressure-guided care is associated with reduced incidence of 6-month rehospitalization, improvement in symptoms or lab indices, lesser new incidence of dialysis, change in use of diuretics, and lesser use of echocardiograms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with minimum 3-month history of Congestive Heart Failure admitted to Aurora St. Luke's Medical Center with acute decompensation
- •English speaking only
排除标准
- •Patients who do not already have a peripheral IV line inserted
- •Patients whose IV line cannot be transduced
- •Patients with current or past vein thrombosis in the arm used to measure the pressure or with history of recurrent (>1) pulmonary embolism
- •Patients with active thrombophlebitis in the arm
- •Patients who have experienced a major cardiovascular event (myocardial infarction, stroke, etc.) ≤2 months prior to the admission date
- •Patients who have received an implanted cardiac resynchronization device (pacemaker or ICD) ≤3 months prior to admission date
- •Patients enrolled in other cardiovascular research studies.
- •Patients with a clinical condition that the investigator believes may not allow the patient to complete the study, at the discretion of the investigator. Examples of conditions that may apply include severe stenotic valvular disease, isolated right ventricle failure, precapillary pulmonary hypertension, hypertrophic obstructive cardiomyopathy, implanted left ventricular assist device, history of heart transplantation, clinical diagnosis of cardiogenic shock, any left-to-right shunt
- •Patients with congenital heart disease or mechanical right heart valve(s)
- •Planned heart surgery and/or coronary intervention during hospitalization
- •Patients expected to receive heart transplant within 6 months of admission
- •IV cannula smaller than 22G
- •Patients who are pregnant and/or lactating
- •Patients who are unable to provide informed consent
- •Patients who are intubated
研究组 & 干预措施
peripheral venous pressure measurements
Peripheral venous pressure measures provided to physicians daily up to 8 days
干预措施: peripheral venous pressure measurements (Other)
standard clinical care
Usual standard clinical care, peripheral venous pressure measures not provided to physician daily
干预措施: standard clinical care (Other)
结局指标
主要结局
Length of hospital stay
时间窗: up to day 8
Number of days from admission to discharge
Number of subjects rehospitalized
时间窗: Day 30 post index hospitalization
Number of subjects in each group who have been rehospitalized
Number of subjects rehospitalized
时间窗: Month 6 post index hospitalization
Number of subjects in each group who have been rehospitalized
次要结局
- Number of subjects with exertional dyspnea(Day 1 and date of discharge (up to day 8))
- Number of subjects with exertional orthopnea(Day 1 and date of discharge (up to day 8))
- Number of subjects with new need for dialysis during index hospitalization(Day 1 and date of discharge (up to day 8))
- Number of subjects with diuretic use(Day 1 and date of discharge (up to day 8))
- Number of subjects with echocardiograms(Day 1 and date of discharge (up to day 8))
- Number of subjects with all-cause death(Month 6 post index hospitalization)
- Number of subjects with cardiac-related death(Month 6 post index hospitalization)