NCT01015313撤回不适用
A Multi-center, Randomized, Controlled and Prospective Pilot Study on the Effects of Intensified Sodium Management on Hospitalization in Chronic Hemodialysis Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- feasibility of intensive sodium management
研究概览
简要总结
The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.
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
- •Ambulatory, clinically stable maintenance hemodialysis patients on a thrice weekly HD regimen.
- •Willing and able to provide written, signed informed consent after the nature of the study has been explained.
- •Willing and able to comply with all study procedures.
- •Age ≥18 years.
排除标准
- •Simultaneous participation in another clinical study except observational trials.
- •Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
- •Pregnancy.
- •Amputation of a limb.
- •Pacemaker, implantable pump, artificial joint.
- •Expectation that native kidney function will recover.
- •Unable to verbally communicate in English or Spanish.
- •Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center within the next 14 months.
- •Life expectancy < 15 months
结局指标
主要结局
feasibility of intensive sodium management
时间窗: 12 months
次要结局
- hospitalization(12 months)
研究者
研究点 (3)
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