Randomized Study Evaluating Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- renal dysfunction at least grade 1 following cisplatin treatment in short hydration group
研究概览
简要总结
The aim of the study is to evaluate safety of short hydration with cisplatin administration. The main outcome is renal dysfunction following cisplatin use with short hydration protocol. Another group of patients received conventional hydration is the historical control for comparison (Randomized phase II design with a reference standard treatment control arm)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patient who has plan to receive first cycle of cisplatin >= 60 mg/m2
- •Normal serum creatinine and creatinine clearance >= 50 ml/min
- •Age < 75 years old
- •Serum albumin >= 3 g/dl
- •Plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist
排除标准
- •The patient who receives other chemotherapy with adminstration volume higher than 500 ml
- •Prior heart failure or known left ventricular ejection fraction > 50%
- •Prior renal dysfunction within 3 months
- •Uncontrolled renal disease
- •current use of diuretic or non-steroidal anti-inflammatory drug (NSAIDs) or starting angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockade (ARB) within 3 months
研究组 & 干预措施
short hydration
Normal saline (NSS) 500 ml infusion in 1 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 500 ml infusion in 1 hour, then NSS 500 ml infusion in 2 hours
干预措施: short hydration (Procedure)
conventional hydration
NSS 1000 ml infusion in 8 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 2000 ml infusion in 16 hour
干预措施: conventional hydration (Procedure)
结局指标
主要结局
renal dysfunction at least grade 1 following cisplatin treatment in short hydration group
时间窗: from starting cisplatin to 4-week after cisplatin discontinuation
increased serum creatinine of 0.3 mg/dl or serum creatinine \>= 1.5-2x upper normal limit
次要结局
- rate of cisplatin modification due to adverse effects in short hydration group(from starting cisplatin to 4-week after cisplatin discontinuation)
- renal dysfunction >= grade 2 following cisplatin treatment in short hydration group(from starting cisplatin to 4-week after cisplatin discontinuation)