NCT04251689已完成2 期
The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
Phramongkutklao College of Medicine and Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年12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
- 48
- 试验地点
- 1
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
This study include cancer patients who had received chemotherapy that include cisplatin. Patients were randomly assigned to either a mannitol 20 g intravenous single dose after cisplatin or a placebo (saline). The primary outcome was to compare acute kidney injury (AKI), which was defined as increase creatinine 0.3 mg/dl in 48 hours by KDIGO criteria using serum creatinine and 24 hour urine creatinine to calculated.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who was at least 18 years old.
- •Patients who had been diagnosed with cancer proven by tissue biopsy.
- •Patients who were scheduled to receive cisplatin or combination of cisplatin and other chemotherapy, which the dose of cisplatin was not exceeded 100 mg/m
- •Patients were required to have a normal renal function (GFR > 60 mL/min/1.73m2).
- •Patients with an Eastern Cooperative Oncology Group (ECOG) score ≤
- •Patients with normal serum sodium and serum potassium level.
排除标准
- •Patients with any acute kidney injury event before randomized into trial not more than 6 months.
- •Patients with chronic kidney disease or hydronephrosis.
- •Patients with history of nephrectomy.
- •Patients who had previously received immunosuppressants for any immune deficiency disease.
- •Patients with who had received chemotherapy which induce nephrotoxicity.
- •Patients with had received drug which is nephrotoxic (amphotericin B, aminoglycoside or non-steroidal anti-inflammatory drug).
- •Patients who had cirrhosis with child pugh score more than
- •Patients with or had a known allergy to cisplatin or mannitol.
- •Patients with chronic heart failure who cannot received fluid more than 1 liter.
- •Patients who were not comfortable to follow up at clinic for long term outcome.
研究组 & 干预措施
intervention
Experimental
mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
干预措施: Mannitol (Drug)
placebo
Placebo Comparator
0.9% normal saline 100 ml one hour after cisplatin
干预措施: Placebo (Drug)
结局指标
主要结局
Acute Kidney Injury
时间窗: 48 hours
Rate of patients with serum creatinine increase 0.3 mg/dl or ≥50% or urine output of \<0.5 mL/kg/hour for \>6 hours by AKIN criteria
次要结局
- Decline 24-hour urine creatinine clearance(48 hours)
研究者
研究点 (1)
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