CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,124
- 试验地点
- 44
- 主要终点
- 60-day All-cause Mortality
研究概览
简要总结
This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.
详细描述
Primary Hypothesis: An intensive management strategy for renal support in critically ill patients with acute renal failure decreases mortality as compared to less intensive (conventionally recommended) management strategies for renal replacement therapy.
Secondary Hypotheses: An intensive management strategy for renal support in critically ill patients with acute renal failure will shorten the duration of ARF, decrease the incidence and duration of non-renal complications and is cost-effective as compared to less intensive (conventionally recommended) management strategies for renal replacement therapy.
Primary Outcomes: 60-day all-cause mortality.
Secondary Outcomes: All-cause hospital mortality; 1-year all cause mortality; recovery of renal function; duration of renal support (dialysis-free days); ICU and hospital length of stay (ICU-and hospital-free days); non-renal organ system failures (organ-failure-free days); and discharge to "home" not on dialysis.
Study Abstract: The optimal management of renal replacement therapy (RRT) in acute renal failure (ARF) is uncertain. The VA/NIH Acute Renal Failure Trial Network (ATN Study) is designed to test the hypothesis that a strategy of intensive renal support will decrease mortality in critically ill patients with ARF as compared to less intensive (conventionally recommended) management. In this multicenter, prospective trial, patients with ARF due to acute tubular necrosis will be randomized equally to intensive or conventional management strategies for RRT.
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
- •Acute renal failure clinically consistent with a diagnosis of acute tubular necrosis
- •Plan for renal replacement therapy by clinical team
- •Receiving care in a critical care unit
- •One non-renal organ failure or sepsis
- •Age 18 or older
- •Patient or surrogate provides informed consent
排除标准
- •Baseline serum creatinine > 2 mg/dL (177 mol/L) in males, > 1.5 mg/dL (133 mol/L) in females
- •Acute renal failure clinically believed to be due to an etiology other than acute tubular necrosis
- •More than 72 hours since meeting both of the following conditions:
- •Fulfillment of the definition of ARF; and
- •BUN > 100 mg/dL (36 mmol/L)
- •More than 1 hemodialysis treatment or more than 24 hours since starting continuous renal replacement therapy
- •Prior kidney transplant
- •Pregnancy
- •Weight > 128.5 kg
- •Non-candidacy for renal replacement therapy
- •Moribund state
- •Patient not expected to survive 28 days because of underlying terminal chronic medical condition
- •Comfort-measures-only status
- •Participation in a concurrent interventional study
- •Patient/surrogate refusal
- •Physician refusal
结局指标
主要结局
60-day All-cause Mortality
时间窗: 60 days
60-day all-cause mortality
次要结局
未报告次要终点