NCT00179166终止2 期
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- whole-body net protein balance
研究概览
简要总结
We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF).
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
- •Adults ≥ 18 years of age admitted to the intensive care unit
- •New onset acute renal failure (ARF) or ARF superimposed on chronic kidney disease
- •ARF will be defined by a sustained (over 24 hours) increase in serum creatinine > 0.5 mg/dl from baseline
- •Patients will be recruited for the study within 3-5 days following establishment of ARF
排除标准
- •Institutionalized patient
- •Previous kidney transplant
- •Pregnancy
- •Unable to obtain consent from subject or legally recognized representative
- •ARF from urinary tract obstruction or a volume responsive pre-renal state.
- •Liver Failure
- •Recent cerebrovascular accident (CVA)
- •Coagulopathy defined as: Platelets < 50, PT > 20, INR > 2.0 if the patient requires the placement of an arterial or venous catheter; if the patient does not require the placement of an arterial or venous catheter for the study, coagulopathy will not be a basis for exclusion.
- •Life expectancy < 48 hours
研究组 & 干预措施
1
Active Comparator
supplement contains protein content of 1.4 g/kg/day
干预措施: TPN nutritional supplement (Drug)
2
Active Comparator
supplement contains protein content of 2.0 g/kg/day
干预措施: TPN nutritional supplement (Drug)
结局指标
主要结局
whole-body net protein balance
时间窗: 10 hours
次要结局
- Net skeletal muscle protein balance(10 hours)
研究者
研究点 (1)
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