Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Serum Creatinine
研究概览
简要总结
Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC) ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.
Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans compared to mannitol and to each other.
Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed using RIFLE criteria. Patients' liver function tests and hematological parameters were also monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients to receive cisplatin based chemotherapy protocol.
- •Adult patients from 18 to 65 years.
排除标准
- •Existing renal impairment ( Creatinine clearance <30 ml/minute)
- •Severe hepatic impairment (Child Pugh score C).
- •Hypersensitivity to sulfonamides.
- •Patients with chronic non-congestive angle closure glaucoma.
- •Hypersensitivity to sulphur compounds, N-acetylcysteine or any component of the formulation.
研究组 & 干预措施
Mannitol group
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
干预措施: Mannitol (Drug)
Mannitol group
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
干预措施: saline (Drug)
Mannitol group
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
干预措施: Cisplatin (Drug)
ACTZ group
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.
干预措施: Acetazolamide (Drug)
ACTZ group
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.
干预措施: saline (Drug)
ACTZ group
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.
干预措施: Cisplatin (Drug)
NAC group
patients received acetylcysteine NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.
干预措施: Acetylcysteine (Drug)
NAC group
patients received acetylcysteine NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.
干预措施: saline (Drug)
NAC group
patients received acetylcysteine NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Serum Creatinine
时间窗: change from baseline after 3 cycles separated by 21 days
Blood samples collected and measured in laboratory with the unit mg/dL
Creatinine clearance according to Cockroft-Gault equation
时间窗: change from baseline after 3 cycles separated by 21 days
calculated using globalrph calculators , unit ml/min
Acute kidney injury
时间窗: change from baseline after 3 cycles separated by 21 days
Acute kidney injury assessed by RIFLE criteria that was calculated for patients
Blood urea nitrogen (BUN)
时间窗: change from baseline after 3 cycles separated by 21 days
Blood samples collected and measured in laboratory with the unit mg/dl
次要结局
- Aspartate Transaminase (AST)(change from baseline after 3 cycles separated by 21 days)
- hemoglo bin(change from baseline after 3 cycles separated by 21 days)
- adverse events(change from baseline after 3 cycles separated by 21 days)
- Alanine Transaminase (ALT)(change from baseline after 3 cycles separated by 21 days)
- platelets count(change from baseline after 3 cycles separated by 21 days)
- total leucocyte count(change from baseline after 3 cycles separated by 21 days)
研究者
Noha Kamal Morsy Ibraheem
clinical pharmacist
Ain Shams University