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临床试验/NCT01403220
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

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

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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