CP0007: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.
研究概览
简要总结
The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.
详细描述
This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.
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
- •Admitted to Heart Failure Unit (H-22) with NYHA class III/IV HF and pulmonary artery catheter in situ
- •Left ventricular ejection fraction <40%
- •Mean Pulmonary Artery Occlusion Pressure ≥20 mm Hg
- •Able to give informed consent
排除标准
- •Currently on renal replacement therapy or determined to need renal replacement therapy at the time of enrollment
- •Estimated glomerular filtration rate (GFR) <15 mL/min
- •Systolic blood pressure (SBP) <80 mm Hg
- •Acute coronary syndrome
- •Hematocrit >50%
- •Malignancy other than prostrate or skin
- •Chronic edematous states other than HF, including nephritic syndrome and cirrhosis
- •Chronic inflammatory or infectious condition
- •Pregnancy
- •Previous enrollment in this study
- •Expectation of need for heart transplantation or cardiac assist device within one week
- •Pulmonary failure requiring intubation and mechanical ventilation
- •Known or suspected hypersensitivity to dialysis membranes
- •Severe aortic stenosis or regurgitation
- •Severe mitral stenosis
研究组 & 干预措施
Ultrafiltration
Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
干预措施: NxStage System One (Device)
Usual & Customary
Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
干预措施: IV loop diuretic (Drug)
结局指标
主要结局
Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.
时间窗: 4 consecutive hours (+/- 30 minutes)
次要结局
- Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.(Time from admission to endpoint achievement)
- Total Volume Removal During the Intervention Period(Intervention start to end.)
- Volume Removal Rate.(Intervention start to end.)
- Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths(Hospital discharge to 90 days after discharge)