NCT00335101撤回4 期
Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Maximum peak increase in SCr from baseline up to day 3.
研究概览
简要总结
The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
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
- •Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as SCr ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.
排除标准
- •Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl < 20 mL/min will not be included.
结局指标
主要结局
Maximum peak increase in SCr from baseline up to day 3.
Secondary endpoints:
Change in SCr from baseline to day 2 and to day 3
Number of subjects with contrast-induced nephropathy (CIN)
Primary endpoint:
Quality of diagnostic information
次要结局
- Coronary Artery Disease (CAD)
- Renal Impairment
- Diabetes mellitus
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Contrast-Induced Nephropathy After Revision of the Prophylaxis ThresholdContrast-induced NephropathyNCT03227835Maastricht University Medical Center1,372
招募中
不适用
Incidence of Acute Kidney Injury After Administration of Iodine Contrast Media in Patients With Reduced Renal FunctionAcute Kidney Injury Following Administration of Contrast MediaNCT06171958Uppsala University400
已完成
不适用
Effects of contrast media for residual renal function in peritoneal dialysis patients.End-Stage Renal Disease (ESRD)JPRN-UMIN000013948agoya University100
终止
4 期
Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk PatientsChronic Renal DiseaseNCT01402219Guangdong Provincial People's Hospital204
终止
4 期
Kidney Damage In Patients With Severe Fall In eGFRCoronary Artery StenosisNCT01136915Bracco Diagnostics, Inc15