Early Application of Renal-Replacement Therapy in Patients With Acute Kidney Injury After Cardiac Surgery: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Number of participants with operative mortality
研究概览
简要总结
Acute kidney injury (AKI) is one of the major complications after cardiac surgery that may affects 20% to 40% of patients according to the definitions. Also, AKI after cardiac surgery is associated with high morbidity and mortality, with eight-fold increase in the odds ratio of death when renal replacement therapy (RRT) is required. However the indication and the optimal timing of RRT initiation are still controversial.
We hypothesized that a strategy of early initiation of RRT would result in a lower risk of surgical mortality than a standard strategy in post cardiac surgery patients with AKI of Kidney Disease: Improving Global Outcomes (KDIGO) classification stage 2 (serum creatinine, 2.0 times the baseline level; urine output, <0.5mL/kg/h for 6 or more hours).
详细描述
This trial was designed as a multi-center randomized, controlled trial to recruit 202 patients who develop acute kidney injury (AKI) described as Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 (serum creatinine, 2.0 times the baseline level; urine output, <0.5mL/kg/h for 6 or more hours) after cardiac surgery. Patients were randomized in a 1:1 ratio to 1 of the 2 treatment groups (Early vs. Delayed renal replacement therapy (RRT)) using a computerized system.
Sample size determination : power calculation were performed based on the primary end point (operative mortality). The expected operative mortality in the control group with delayed initiation of RRT was 55% based on the literature. Differences between treatment groups were to be detected with a power of 80%, if the operative mortality of with early initiation of RRT was 35% or less. The expected treatment effect of 20% was calculated on the mortality differences between early and delayed RRT reported in previous studies. A required sample size for the final analysis was 101 patients per treatment group, 202 patients in total (level of significance, α = 0.05; type II error, β= 0.02; potential dropouts= 5%).
Early RRT was initiated within 6 hours of diagnosis of stage 2 AKI.
Delayed RRT was initiated if any one of the following absolute indications for RRT is present
- serum urea level higher than 100mg/dL and/or with uremic encephalopathy
- serum potassium level higher than 6mmol/L and/or with electrocardiography abnormalities
- urine production lower than 0.3mL/kg/hr for 24 hours
- pH of 7.15 or less and/or severe hypotension due to metabolic acidosis
- organ edema in the presence of AKI resistant to diuretic treatment.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients within 7 days after cardiac surgery
- •Acute kidney injury (AKI) described as Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 (urine output <0.5mL/kg/h for ≥6h or 2-fold increase in serum creatinine compared with baseline)
排除标准
- •previous renal replacement therapy
- •AKI secondary to obstructive nephropathy
- •previous kidney transplantation
研究组 & 干预措施
Early RRT group
Patients who will undergo renal replacement therapy (RRT) within 6 hours of diagnosis of stage 2 acute kidney injury (AKI).
干预措施: Renal replacement therapy (Other)
Delayed RRT group
Patients who will undergo renal replacement therapy (RRT) if one of the absolute indications for RRT is present.
干预措施: Best medical management (Other)
结局指标
主要结局
Number of participants with operative mortality
时间窗: at postoperative 30 days
any death, regardless of cause, occurring (1) within 30 days after surgery in or out of the hospital, and (2) after 30 days during the same hospitalization subsequent to the operation
次要结局
- Number of participants with renal replacement therapy dependency(at postoperative 90 days)
- Number of participants with major adverse kidney events (MAKE)(at postoperative 90 days)
- Number of participants with cardiovascular mortality(at postoperative 90 days)
- Hospital length of stay(at postoperative 30 days)
- Overall survival(at postoperative 90 days)
- Number of participants with renal replacement therapy related morbidity(at postoperative 90 days)
- Duration of mechanical ventilation(at postoperative 30 days)
- Duration of intensive care unit stay(at postoperative 30 days)
研究者
Ho Young Hwang
Professor
Seoul National University Hospital