NCT03391830已完成不适用
Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy. Randomised Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Contrast Induced-Acute Kidney Injury
研究概览
简要总结
To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography urogram (CTU).
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
- Double (Participant, Investigator)
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
- •Planned computed tomography urogram (CTU)
- •Statin naive, or not on statin treatment for at least 14 day
排除标准
- •History of liver disease or elevated serum transaminases
- •History of rhabdomyolysis or elevated creatinine kinase
- •History of iodinated CM use within 14 days before randomization
- •History of N-acetylcysteine, metformin or nonsteroidal anti-inflammatory drugs use within 48 hours of the procedure.
- •History of hypersensitivity reaction to contrast media
- •Pregnancy or lactation
- •Acute renal failure
- •End-stage renal disease requiring dialysis
- •Cardiogenic shock or pulmonary edema
- •Multiple myeloma
研究组 & 干预措施
Atorvastatin-Ascorbic acid
Active Comparator
atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg
干预措施: Atorvastatin-Ascorbic acid (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Contrast Induced-Acute Kidney Injury
时间窗: 3 days
Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure.
次要结局
- long-term Renal function by estimated GFR(30 days)
研究者
Abdelwahab Hashem
Clinical Uro-oncology Fellow - Urology and Nephrology Center - Mansoura
Mansoura University
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary AngiographyContrast Induced NephropathyNCT02113540Isfahan University of Medical Sciences
已完成
4 期
Ameliorating Contrast Induced Nephropathy After Coronary AngiographyCoronary Artery DiseaseToxic, Drugs NephropathyNCT06139952Ain Shams University120
已完成
2 期
Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in GlioblastomaGlioblastoma MultiformeNCT02029573King Fahad Medical City36
已完成
4 期
Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)AngioplastyPercutaneous CoronaryMyocardial InfarctionNCT00808717Yonsei University170
已完成
4 期
The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic SurgeryAortic SurgeryAcute Kidney InjuryNCT02157337Yonsei University23