NCT00870883已完成2 期
Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Development of acute renal failure
研究概览
简要总结
Oxidative stress is associated with kidney damage in several different situations, including hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine could prevent renal failure in critical ill patients who develops hypotension.
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
- Double (Participant, Investigator)
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
- •Patients admitted to the ICU
- •Presenting hypothesion (MAP < 60mm Hg or the needing to use vasoactive drugs) for at least 30 min in the last 12h before study inclusion
排除标准
- •Age lower than 18 years old
- •Chronic renal failure
- •A known history of allergy to any of the study drugs
- •Using n-acetylcysteine to paracetamol overdose
- •Pregnant women
- •Patients who used iodinated contrast medium
- •Hemoglobin less than 6.5 mg/dl
- •Cancer patients
研究组 & 干预措施
N-acetylcysteine plus deferoxamine
Experimental
干预措施: N-acetylcysteine and deferoxamine (Drug)
结局指标
主要结局
Development of acute renal failure
时间窗: 28 days
次要结局
- 28 day-mortality(28 days)
- Decrease on plasma oxidative damage and inflammatory parameters(at the end of drug infusion)
研究者
Felipe Dal Pizzol
MD, PhD
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
研究点 (1)
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