To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography： A Multi-center Randomized Control Trail
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,368
- 试验地点
- 1
- 主要终点
- CIN
研究概览
简要总结
To Compare Intravenous and Oral Hydration of the Prevention for Contrast-induced Nephropathy in Elderly Patients Undergoing Intravenous Contrast-enhanced Computed Tomography.
详细描述
The prospective multicenter randomized controlled clinical research discusses the comparison of oral and intravenous hydration for prevention of contrast-induced nephropathy in elderly patients with enhanced computed tomography, establishing a simple hydration proposal.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •Undergoing Intravenous Contrast-enhanced Computed Tomography
排除标准
- •CT enhancement was not performed;
- •Dialysis treatment of patients with end-stage renal failure or heart, kidney transplantation;
- •Exposure to radioactive contrast medium within 48 hours prior to or within 72 hours of examination;
- •Acute decompensated heart failure;
- •Allergic to radioactive contrast agent;
- •Be subjected to life - threatening trauma;
- •Severe infection;
- •Surgery was performed within 2 days of CT examination.
- •Combined with multiple myeloma, urinary obstruction, aortic dissection
- •Can cause acute kidney injury disease;
- •Use of aminoglycosides and other nephrotoxic drugs 2 weeks before.
研究组 & 干预措施
distilled water
Oral distilled water at the rate of 3 mL/kg/h rate during undergoing enhanced computed tomography examination before 1-2 and after 4-6 hours
干预措施: enhanced computed tomography (Procedure)
Saline
intravenous saline hydration at the rate of 1 mL/kg/h rate during undergoing enhanced computed tomography examination before and after 12 hours
干预措施: enhanced computed tomography (Procedure)
结局指标
主要结局
CIN
时间窗: 72hours
Compared with before examination, the increase of serum creatinine conforms to the diagnostic criteria of contrast induced nephropathy.
次要结局
未报告次要终点
研究者
Yu Danqing
Director,Clinical Professor
Guangdong Academy of Medical Sciences