Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L)
研究概览
简要总结
In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography, coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function
详细描述
Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who undergo coronary catheterization
- •creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula
排除标准
- •pregnancy or lactation
- •having received contrast media within 7 days of study entry
- •emergent coronary angiography
- •acute renal failure or end-stage renal disease requiring dialysis
- •history of hypersensitivity reaction to contrast media
- •unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
- •multiple myeloma
- •parenteral use of diuretics
- •use of N-acetylcysteine
- •use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure
研究组 & 干预措施
iopromide
干预措施: contrast agent (iopromide) (Drug)
iodixanol
干预措施: contrast agent (iodixanol) (Drug)
结局指标
主要结局
Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L)
时间窗: days 1 and 2
次要结局
- proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine(days 1 and 2)