NCT03329443已完成2 期
The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography
Alhasan Mujtaba Abdul-Wahid1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2017年9月1日最近更新:
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
- 490
- 试验地点
- 1
- 主要终点
- Acute kidney injury by K-DIGO guidelines
研究概览
简要总结
an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography
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
- •patients admitted to angiography unit
- •informed consent
排除标准
- •acute renal failure before 7 days
- •spironolactone contraindications
- •hyperkalemia (S.K. >5.5 mEq/L)
- •documented tumor
- •actively taking NSAIDs, Ciclosporin, Cisplatin,
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: Placebo Oral Tablet (Drug)
Spironolactone
Active Comparator
干预措施: Spironolactone (Drug)
结局指标
主要结局
Acute kidney injury by K-DIGO guidelines
时间窗: 48-72 hrs
an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline
次要结局
- acute kidney injury by NGAL(6 hours)
研究者
Alhasan Mujtaba Abdul-Wahid
Clinical pharmacy specialist
University of Baghdad
研究点 (1)
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