Blood Volume Analysis - Guided Heart Failure Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Whole Blood Volume
研究概览
简要总结
The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.
详细描述
The purpose of this study is to better understand measurements of various parameters of congestion, the most significant of which is blood volume analysis. Blood volume analysis (BVA) measures how much blood is in the investigator's arteries and veins and is performed by using an IV and injecting a small amount of a radioactive material (I 131-labeled albumin). The study also involves blood tests, urine tests, blood pressure monitoring, an ultrasound, and measurement of lung fluid volume (by way of a vest). There will also be a 30-day follow-up phone call to assess symptoms and discuss any changes in medication.
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
- Double (Participant, Care Provider)
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
- •Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina
排除标准
- •Age < 18 years
- •Ongoing pregnancy
- •Recent acute MI or hemodynamic instability: Acute MI (STEMI or Type I NSTEMI) within 7 days
- •Post heart transplantation or ongoing mechanical circulatory support
- •Progressive cardiogenic shock
- •Patients with Ventricular Assist Devices
- •End stage renal disease
结局指标
主要结局
Change in Whole Blood Volume
时间窗: Baseline, and upon discharge (up to day 18)
次要结局
- Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)(Baseline, day 1, day 2, day 3 and discharge (up to day 18))
- Change in Pulmonary Congestion as Measured Using Non-invasive Diagnostic Technology Such as the ReDS Vest (Radiofrequency) or Bio-impedance Based Technologies (Unitless Values)(Baseline, day 1, day 2, day 3 and discharge (up to day 18))
- Change in Mean NTpro-BNP Concentration (in pg/mL)(Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge)
- Change in Renal Function as Measured by Creatinine (mg/dL)(Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge)
- Change in Weight (in kg)(Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge)
- Change in Renal Function as Measured by an Estimated Glomerular Filtration Rate (mL/Min/ 1.73m2)(Baseline, day 1, day 2, day 3 and discharge (up to day 18))
- Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)(Baseline, day 1, day 2, day 3 and discharge (up to day 18))