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临床试验/NCT01569698
NCT01569698终止不适用

Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

Rennes University Hospital19 个研究点 分布在 3 个国家目标入组 310 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
310
试验地点
19
主要终点
extra renal replacement therapy

研究概览

简要总结

Limited prospective data is available to compare morbidity and mortality between renal replacement modalities in pediatric acute renal failure.

In the absence of clear standard of care, the choice of the extra renal replacement therapy modality is subject to clinical judgement, practical aspects, and costs.

This study will supply important data about usual modalities of pediatric acute extra renal replacement therapy and their impact on patient outcome and renal recovery. An obvious next step will be to conduct a randomized controlled trial comparing the different strategies.

详细描述

In children, there are limited data on extra renal replacement therapy. Pediatric studies are often retrospective, or often limited to specific disease processes or specific extra renal therapy. The lack of large studies including different usual modalities in pediatrics limits any formal recommendation on use in relation to patient outcomes, including renal recovery and mortality. Some of the issues that need consideration are the choice of dialysis modality (including Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis), the indications for and timing of dialysis intervention, the dose of dialysis and their effects on outcomes from acute kidney injury in children.

This study will supply important data about pediatric acute extra renal replacement therapy, including the epidemiology of pediatric acute kidney injury leading to extra renal replacement therapy, the variety of the treatment modalities, and their effects on the course of the disease.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age < 18 years, including the newborn ;
  • Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method.

排除标准

  • Treatment by extra renal replacement therapy for terminal renal failure;
  • History of renal transplantation;
  • Extra renal replacement therapy for an inborn errors of metabolism without acute renal failure;
  • Extra renal replacement therapy in the context of a drug intoxication without acute renal failure;
  • Treatment by technique in MARS (Molecular Adsorbent Recirculating System);
  • Modified ultrafiltration during surgery.

结局指标

主要结局

extra renal replacement therapy

时间窗: at day 60 +/- 7

To describe usual modalities of pediatric acute extra renal replacement therapy including Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis.

次要结局

  • Current incidence(at day 60 +/- 7)
  • etiologies(at day 0)
  • Risk factors of mortality and non recovery of the renal function(at day 60)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (19)

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