Comparative Evaluation of the Effect of Theophylline Plus N-acetylcysteine, Theophylline Alone, and N-acetylcysteine Alone in Preventing Contrast-induced Nephropathy in Patients With Moderate to High Risk Undergoing Coronary Angiographic Procedures
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Plasma creatinine level
研究概览
简要总结
The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy. Investigators assume that Theophylline plus N-acetylcysteine is more effective than Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for elective coronary angiography or angioplasty and allocate them to each of the mentioned treatments from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •candidate of elective coronary angiography or angioplasty
- •at least moderate risk for contrast induced nephropathy
排除标准
- •unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
- •unstable serum creatinine
- •unstable hemodynamic
- •intravascular administration of contrast material in the past month
- •using theophylline or N-acetylcysteine in the past month,
- •known hypersensitivity to theophylline or N-acetylcysteine
研究组 & 干预措施
N-acetylcysteine
Patients in the N-acetylcysteine group receive 600 mg non-effervescent N-acetylcysteine tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material.
干预措施: N-acetylcysteine (Drug)
N-acetylcysteine
Patients in the N-acetylcysteine group receive 600 mg non-effervescent N-acetylcysteine tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material.
干预措施: 0.9% sodium chloride (Drug)
Theophylline
Patients in the Theophylline group receive 200 mg Theophylline slow-release tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material.
干预措施: Theophylline (Drug)
Theophylline
Patients in the Theophylline group receive 200 mg Theophylline slow-release tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material.
干预措施: 0.9% sodium chloride (Drug)
Theophylline plus N-acetylcysteine
Patients in the Theophylline plus N-acetylcysteine group receive Theophylline slow-release 200 mg tablet plus non-effervescent N-acetylcysteine 600 mg tablet twice daily from 24 hours before to 48 hours after administration of contrast material.
干预措施: N-acetylcysteine (Drug)
Theophylline plus N-acetylcysteine
Patients in the Theophylline plus N-acetylcysteine group receive Theophylline slow-release 200 mg tablet plus non-effervescent N-acetylcysteine 600 mg tablet twice daily from 24 hours before to 48 hours after administration of contrast material.
干预措施: Theophylline (Drug)
Theophylline plus N-acetylcysteine
Patients in the Theophylline plus N-acetylcysteine group receive Theophylline slow-release 200 mg tablet plus non-effervescent N-acetylcysteine 600 mg tablet twice daily from 24 hours before to 48 hours after administration of contrast material.
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
Plasma creatinine level
时间窗: up to 48h after contrast injection
Plasma creatinine level is measured at baseline and after 48 hours of contrast injection. Increase in plasma creatinine level ≥ 0.5 mg/dL or ≥ 25% of the baseline creatinine after 48 hours of contrast injection will be considered contrast induced nephropathy.
次要结局
未报告次要终点
研究者
Mortaza Arabmomeni
Dr.
Isfahan University of Medical Sciences