NCT00736866已完成3 期
A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Contrast-induced nephropathy incidence
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.
Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least one of the following criteria:
- •Aged more than 70 years-old
- •Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months)
- •Diabetes mellitus
- •Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45)
- •Shock or intra-aortic balloon pump use
- •Urgency or emergency procedures
排除标准
- •Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.
- •Patients in dialysis
- •Previous inclusion in this trial
- •Patient refusal to informed consent
- •Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.
研究组 & 干预措施
Acetylcysteine
Experimental
干预措施: Acetylcysteine (Drug)
Control
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Contrast-induced nephropathy incidence
时间窗: between 48 and 96 hours after angiographic procedures
次要结局
- Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication(within 30 days)
- Combined outcome of total mortality or dialysis indication(within 30 days)
- The individual components of the combined outcome(within 30 dias)
研究者
研究点 (1)
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