NCT02481518已完成4 期
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute kidney injury
研究概览
简要总结
The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).
详细描述
Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Eastern Cooperative Oncology Group score 0-2
- •First Diagnosed Head and neck cancer and plan for treatment with cisplatin
- •Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)
排除标准
- •Prior treatment with cisplatin before randomization
- •Uncontrolled concurrent disease
- •Pregnancy
研究组 & 干预措施
Magnesium
Experimental
Magnesium preloading group : Magnesium preloading for Cisplatin treatment
干预措施: Magnesium (Drug)
Control
Active Comparator
Control group : Normal saline preloading for cisplatin treatment
干预措施: Control (Other)
结局指标
主要结局
Acute kidney injury
时间窗: 7 days after cisplatin administration
Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment
次要结局
- Nephrotoxicity(up to 12 weeks)
研究者
研究点 (1)
Loading locations...
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