NCT01403220已完成不适用
The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2012年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
研究概览
简要总结
The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •According to RIFLE score, patient is stage 'F'
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient meets at least one of the following criteria:
- •metabolic acidosis (pH < 7.2), excluding keto-acidosis
- •plasma urea > 25 mmol/l
- •hyper-hydration is not controlled by diuretics
排除标准
- •Chronic, terminal renal insufficiency with dialysis
- •The patient is under judicial protection, under tutorship or curatorship
- •Suspect hyperkaliemia (Kaliemia > 6.5 mmol/l with electrocardiographic effects)
- •Intoxications treated via dialysis
- •Pregnant, lactating, parturient women
- •Medical indication for localized citrate anticoagulation
- •dialysis of less than 12 h
- •patient or representative refuses to participate
结局指标
主要结局
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
时间窗: 12 hours
Proportion of dialysis sequences for which the rate of plasma urea reduction \> 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.
次要结局
- Filter lifespan (hours) for the dialysis sequence under study.(12 hours.)
- Fluid replacement (yes/no)(24 hours)
- Urea clearance (ml/min) for the dialysis sequence under study(12 hours)
- Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.(24 hours)
- The percentage down-time for the first 24 hours of dialysis(24 hours)
研究者
研究点 (2)
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