NCT00368641终止2 期
Treatment-Resistant Heart Failure (HF) and Peritoneal Ultrafiltration (PUF): A Randomized Prospective Trial of Standard Care Versus Standard Care With Peritoneal Ultrafiltration in Patients With Treatment-Resistant Severe Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- All-cause Hospitalization (Unadjusted)
研究概览
简要总结
The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.
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
- •Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.
排除标准
- •Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.
研究组 & 干预措施
Intervention
Experimental
peritoneal dialysis
干预措施: Extraneal (Drug)
结局指标
主要结局
All-cause Hospitalization (Unadjusted)
时间窗: 6 to 24 months
All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.
次要结局
未报告次要终点
研究者
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