Early Versus Late Renal Replacement Therapy In Mechanically Ventilated Patients With Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Early renal replacement therapy (RRT) group
In this group of patients, RRT will be initiated if the patient either presents with or develops AKI, while mechanically ventilated, provided that he is in stage 2 according to KDIGO classification.
RRT will not be delayed till the presence of an urgent indication for the procedure.
A trial of furosemide stress test will be applied before proceeding towards early RRT after volume optimization.
干预措施: Renal replacement therapy (Procedure)
Late renal replacement therapy (RRT) group
This group of patients will receive RRT if they develop any of the following indications:
- Severe hyperkalemia (> 6.5 mEq/L).
- Oliguria with failed response to diuretics in the presence of life-threatening pulmonary edema requiring high ventilatory settings i.e. PEEP >10 in addition to FiO2 > 50%.
- Severe metabolic acidosis (PH <7.15).
- Uremic pericarditis, encephalopathy or coagulopathy.
干预措施: Renal replacement therapy (Procedure)
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)