Artificial Kidney Initiation in Kidney Injury, a Multicenter Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:
- an "early" strategy where RRT is started immediately when a RIFLE F status is documented
- a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.
详细描述
Background:
Acute kidney injury (AKI) is a common complication in intensive care unit (ICU) patients. Renal replacement therapy (RRT) is the major supportive treatment of AKI. Despite progress in RRT management, mortality remains high and the timing of its initiation remains open to debate when no metabolic disorder (severe hyperkalemia or metabolic acidosis) or major fluid overload threaten short-term prognosis. Such abnormalities mandate RRT and are non-inclusion criteria of our study. Whereas many studies have focused on RRT modalities, no prospective randomized study has evaluated the criteria for initiating RRT in ICU in the absence of the above-mentioned life-threatening disorders. In other words, whether duration of oliguria/anuria and/or value of serum urea/creatinine are an adequate indication for RRT is unknown. Given the lack of high quality data, it is not surprising that survey of practices showed wide variation in the timing of RRT initiation and that no precise guidelines could be drawn by expert recommendation as to the optimal start of RRT, making a randomised controlled study of timing of RRT both desirable and ethical.
Objective:
The main objective of this study is to compare two strategies of RRT initiation in terms of overall survival in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:
- an "early" strategy where RRT is started immediately when a RIFLE F status is documented
- a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
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
- None
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
- •The following five criteria are required for inclusion
- •Hospitalized in intensive care unit
- •Age ≥ 18 years
- •Acute kidney injury compatible with the diagnosis of acute tubular necrosis defined by a clinical ischemic or toxic insult context
- •Have an AKI classified as RIFLE F, that is to say, with at least one of the following three criteria:
- •creatinine> 354 mmol / l or > 3 times the baseline creatinine
- •anuria for more than 12 hours
- •oliguria defined as urine output < 0.3 ml / kg / h or < 500ml/d for more than 24 hours
- •Mechanical ventilation and/or catecholamines infusion (noradrenaline or/and adrenaline)
- •Non-inclusion criteria
- •One or more of the following criteria:
- •Chronic renal failure (defined as creatinine clearance < 30 ml / min)
- •Patients already enrolled in the study
- •Inclusion criteria number 4 present for more than 5 hours
- •Acute renal failure due to:
- •urinary tract obstruction
- •renal vessels obstruction
- •tumor lysis syndrome
- •thrombotic microangiopathy
- •acute glomerulonephritis
- •Intoxication with a dialyzable product
- •Child-Pugh class C liver cirrhosis
- •Renal transplant
- •Cardiac arrest without awakening at time of potential inclusion
- •Moribund state
- •Decision to limit treatment
- •RRT already started for the current episode of AKI
- •Presenting (at the time of potential inclusion) a strong indication for immediate RRT
- •oligoanuria for more than 3 days
- •serum urea concentration > 40 mmol / l serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
- •Under cardiopulmonary bypass
- •Included in another clinical trial on RRT modalities.
排除标准
- 未提供
研究组 & 干预措施
Delayed RRT strategy
The "delayed" strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the "Alert Criteria"
干预措施: Delayed RRT strategy (Procedure)
Early RRT strategy
the "early" strategy : RRT is started immediately when a RIFLE F status is documented
干预措施: Early RRT strategy (Procedure)
结局指标
主要结局
Overall survival
时间窗: 60 days
The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.
次要结局
- length of stay in ICU and hospital(60 days)
- rate of nosocomial infections(28 days)
- rate of ventilator free days(28 days)
- Survival rate(28 days)
- time to withdrawal RRT(28 days)
- rate of RRT free days(28 days)
- rate of vasopressors free days(28 days)
- percentage of patients requiring at least a RRT in the "waiting" strategy(28 days)
- rate of adverse events potentially related to the AKI or RRT(28 days)
- rate of limitations of treatment(28 days)
- total cost of consumables related to RRT(28 days)