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临床试验/NCT03763188
NCT03763188已完成不适用

Daily Urinary Urea Excretion to Guide Renal Replacement Therapy Weaning in Intensive Care Units

Dr Alexandre Gros1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2016年9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
260
试验地点
1
主要终点
the catheter free days

研究概览

简要总结

Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in Intensive Care Units.

The objective is to show that remove the dialysis catheter, once daily urinary urea excretion is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis catheters, and thus without dialysis, the first 28 days after insertion.

Daily urinary urea excretion = urea (mmol/L) x diuresis (L/d) / weight (kg).

详细描述

Daily urinary excretion of urea may provide a safe and reproducible renal replacement therapy withdrawal criterion, according to a recent French study (citations). A rate greater than 1.35 mmol/kg/d would predict a weaning success of 97.1% at 1 week. This criterion is influenced by the use of diuretics, and is easily accessible and achievable. Daily urinary urea excretion is representative of the recovery of renal function. The French study establishing this new withdrawal criterion was monocentric and retrospective. However, we changed our practices as soon as we became aware of them.

French multicentric (Bordeaux University Hospital, Libourne, Pau and Bayonne Hospitals) study, before and after:

  • Period before: patients who were dialysed in the intensive care units of Bordeaux, Libourne, Pau and Bayonne, from November 2013 to November 2015.
  • Period after: patients selected prospectively in the 4 hospitals.

When diuresis > 100 ml/d, an urinary ionogram is realized daily. Measurement of urinary urea excretion every day. Ablation of the catheter as soon as daily urinary urinary excretion > 1.35 mmol/kg/d.

Measurement of daily urinary excretion the following 3 days.

研究设计

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

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

  • All patients > 18 of age, who have a Renal Replacement Therapy, in intensive care unit,
  • with a diuresis > 100 ml/d.

排除标准

  • Patients still presenting "hard" criteria for RRT: metabolic acidosis with pH < 7.15 and PCO2 <50mmHg; acute pulmonary edema (> 5l 02 or 50% FiO2 for Sp02 > 95%) objectified by echocardiography; K> 5.5 mmol/l after treatment
  • Renal transplantation
  • Long-term chronic kidney injury or short-term dialysis project (arteriovenous fistula created).
  • Acute Kidney Injury secondary to thrombotic microangiopathy
  • Acute Kidney Injury secondary to an obstacle even if dialysed
  • RRT started for toxic cause without IRA (lithium,...)

结局指标

主要结局

the catheter free days

时间窗: the first 28 days after catheter insertion

days

次要结局

  • Renal therapy replacement complications (hemorrhage, heparin-induced thrombocytopenia, other)(the first 28 days after catheter insertion)
  • number of dialysis catheter laid per patients(the first 28 days after catheter insertion)
  • new dialysis catheter and new renal replacement therapy(the first 7 days after dialysis catheter ablation)
  • Dialysis catheters infections(the first 28 days after catheter insertion)
  • Duration of renal replacement therapy(the first 28 days after catheter insertion)
  • Duration of mechanical ventilation(the first 28 days after catheter insertion)
  • Duration of ICU stay(the first 28 days after catheter insertion)
  • Mortality at at day 28(the first 28 days after catheter insertion)

研究者

发起方
Dr Alexandre Gros
申办方类型
Indiv
责任方
Sponsor Investigator
主要研究者

Dr Alexandre Gros

GROS, Alexandre, Medical Doctor, Intensive Care Unit, Principal Investigator

Gros, Alexandre, M.D.

研究点 (1)

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