The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care
2015年3月26日 更新者:Centre Hospitalier Universitaire de Nīmes
The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study
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.
研究概览
研究类型
介入性
注册 (实际的)
163
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Gard
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Nîmes Cedex 09、Gard、法国、30029
- Centre Hospitalier Universitaire de Nîmes
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Group 1 (hemodiafiltration first)
This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.
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Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.
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有源比较器:Group 2 (hemofiltration first)
This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.
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Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
大体时间:12 hours
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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.
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12 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
大体时间:24 hours
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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.
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24 hours
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Urea clearance (ml/min) for the dialysis sequence under study
大体时间:12 hours
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Urea clearance (ml/min) for the dialysis sequence under study.
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12 hours
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Filter lifespan (hours) for the dialysis sequence under study.
大体时间:12 hours.
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Filter lifespan (hours) for the dialysis sequence under study.
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12 hours.
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The percentage down-time for the first 24 hours of dialysis
大体时间:24 hours
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The percentage down-time for the first 24 hours of dialysis = (number of hours where the exchange is not effective / 24 hours)*100
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24 hours
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Fluid replacement (yes/no)
大体时间:12 hours
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Was fluid replacement necessary during the studied dialysis sequence?
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12 hours
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Fluid replacement (yes/no)
大体时间:24 hours
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Was fluid replacement necessary during the studied dialysis sequence?
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24 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Pascal Jeannes, MD、Centre Hospitalier Universitaire de Nîmes
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Bruggemann RJ, Lefrant JY, Roberts JA. Caspofungin Population Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-Venous Haemofiltration or Haemodiafiltration. Clin Pharmacokinet. 2017 Sep;56(9):1057-1068. doi: 10.1007/s40262-016-0495-z.
- Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Lefrant JY, Roberts JA. Influence of Renal Replacement Modalities on Amikacin Population Pharmacokinetics in Critically Ill Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4901-9. doi: 10.1128/AAC.00828-16. Print 2016 Aug.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年4月1日
初级完成 (实际的)
2015年2月1日
研究完成 (实际的)
2015年2月1日
研究注册日期
首次提交
2011年7月25日
首先提交符合 QC 标准的
2011年7月26日
首次发布 (估计)
2011年7月27日
研究记录更新
最后更新发布 (估计)
2015年3月27日
上次提交的符合 QC 标准的更新
2015年3月26日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Hemodiafiltration first的临床试验
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