NCT01580046Unknown4 期
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction-a Multicentre, Single Blind, Randomized Controlled, Prospective Trial
Yong Huo19 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate
研究概览
简要总结
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.
详细描述
The study is designed to compare renal toxicity of Iodixanol and Iopromide after coronary angiography or percutaneous coronary intervention (PCI) in patient with Chronic Kidney Disease, considering original renal function and adequate hydration. The risk of varying degree of renal impairment, changes of serum Cys C level will also be evaluated.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides written Informed Consent and is willing to comply with protocol requirements
- •Is referred for cardiac angiography, with or without PCI
- •Has a documented predose serum creatinine level of 1.5～3.5 mg/dl for men and 1.3～3.0 mg/dl for women
- •Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment)
排除标准
- •Has a history of hypersensitivity to iodine-containing compounds
- •Has end-stage renal disease
- •Has kidney transplantation
- •Has creatinine clearance rates >60 ml/min in last 3 months
- •Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock
- •Patients with cancer
- •Has diabetes with serious complications, other kidney organs
- •Patients with serious blood system disease
- •Heart failure [class III~Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema]
- •Patients with hepatic insufficiency[3 times as ALT and (or) AST normal reference value limit]
- •Has received an iodinated contrast agent within 14 days prior to the administration of the study agent
- •Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent
- •Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months
- •Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure
- •Patients with hypotension [(SBP<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) ]
- •Uncontrolled condition of hyperthyroidism
- •pregnancy or lactation
- •Is planned to receive the drugs without permission in this protocol
- •Participating in another intervention research study in last 3 months
- •legally incapacitated or limitations
- •Any other conditions not suitable to be enrollment
研究组 & 干预措施
Iodixanol
Experimental
干预措施: iodixanol (Drug)
iopromide
Active Comparator
干预措施: iopromide (Drug)
结局指标
主要结局
to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate
时间窗: days 3 and 7
次要结局
- In each group(Iodixanol group and Iopromide group), the proportion of patients exhibiting an increases of serum creatinine in different range(<10%,10%~25%, and ≥25%), comparing with baseline level.(days 3 and 7)
- Changes of Cystatin C level from baseline(days 1 and 3)
- Incidence of hemodialysis(days 3 and 7)
研究者
Yong Huo
MD
Peking University First Hospital
研究点 (19)
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