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临床试验/NCT05382598
NCT05382598已完成不适用

Early Versus Late Renal Replacement Therapy In Mechanically Ventilated Patients With Acute Kidney Injury

Alexandria University2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
mortality

研究概览

简要总结

This is a randomized controlled study that will be conducted on acute kidney injury (AKI) patients, who are mechanically ventilated, to assess the impact of implementation of early renal replacement therapy (RRT) compared to late RRT on patients outcome.

详细描述

The study subjects will be randomly divided into two groups (arms).

The first one will be patients who will receive early renal replacement therapy (RRT) according to predefined criteria that will be illustrated later.

The other group of patients will be those who receive late RRT according to the absolute indications of emergency hemodialysis i.e. severe hyperkalemia, life-threatening acidosis, uremic encephalopathy or pericarditis in addition to intractable pulmonary edema.

Appropriate randomization technique will be applied. A computer-based program will be used to perform the randomization procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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 must be on invasive mechanical ventilation.
  • Patients in AKI stage 2 , according to KDIGO classification.
  • Recruited subjects will include either those who present with AKI on their ICU admission or those who develop AKI during their ICU stay

排除标准

  • Those who are known to be in grade 5 CKD according to KDIGO classification. All other grades of CKD from 1 to 4 will be included only if they develop or present with stage 2 AKI on top of their CKD grade
  • Those who develop AKI due to obstructive or traumatic causes.
  • Patients with septic shock who are on high doses of vasopressors or inotropes (norepinephrine infusion more than 1 mcg/kg/minute, dopamine or dobutamine infusion more than 5 mcg/kg/minute).
  • Pregnant females

结局指标

主要结局

mortality

时间窗: 28 days

ICU mortality

Weaning of mechanical ventilation

时间窗: through study completion, an average of 1 year

duration of mechanical ventilation

ICU length of stay

时间窗: through study completion, an average of 1 year

Duration of ICU stay

次要结局

  • Renal functions on discharge from ICU(through study completion, an average of 1 year)
  • RRT dependency(for more than three months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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