Bioimpedance Versus Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 主要终点
- All cause mortality
研究概览
简要总结
The investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and arterial stiffness.
详细描述
The investigators developed a randomized controlled study to compare exclusively bioimpedance guided ultrafiltration in hemodialysis patients versus traditional methods for volume assessment.
The duration of the study was 3,5 years.
During the first 2,5 years of the study all enrolled patients were randomized using a block randomization algorithm in two arms.
In the interventional arm the post-dialysis dry weight was prescribed exclusively using the BCM device (Body Composition Monitor - Fresenius Medical Care, Germany).
In the control arm dry weight assessment was done by traditional clinical methods.
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
- •older than 18-year
- •on chronic hemodialysis for more than 3 months
排除标准
- •life expectancy of less than 1 year
- •Presence of a condition that may interfere with the determination of dry weight using the Body Composition Monitor (R):
- •severe ascites (decompensated liver failure)
- •limb amputations
- •cardiac stent, pacemaker or defibrillator
- •hip prosthetic
- •pregnancy
- •mental deficiency (impossibility to give consent)
结局指标
主要结局
All cause mortality
时间窗: 2,5 years follow-up
We assessed all-cause mortality in the two arms of the study at the end of intervention period.
次要结局
- Arterial stiffness(3,5 years)
- Blood pressure values(2,5 years)
- Overhydration(2,5 years)
研究者
Professor Adrian Covic
Professor Dr.
Grigore T. Popa University of Medicine and Pharmacy