The Optimal Hydration With Sodium Chloride in High Risk Patients Undergoing Coronary Angiography, Reduction of Risk of Contrast-associated Acute Kidney Injury After Cardiac Catheterization 2 (TIME RESCIND 2) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,002
- 试验地点
- 1
- 主要终点
- Contrast-associated acute kidney injury a
研究概览
简要总结
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients. The investigators will compare long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the short term hydration may not be inferior to the long one.
详细描述
No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients undergoing coronary angiography. Long term hydration at routine speed(12h before and after procedure at 1ml/kg/h), as the most recommended adequate hydration, has been carried out to prevent contrast-associated acute kidney injury in lots of clinical trials. Base on the data in the POSEIDON randomized controlled trial with hemodynamic-guided fluid administration, short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) may not be inferior to the classic long term hydration, the speed should be reduced half of the intended speed in all the patients. We hypothesized short term hydration may not be inferior to the long one to reduced significantly the hospital stay and healthy cost.
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
- None
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
- •≥18 years of age;
- •Written informed consent;
- •Candidates scheduled for coronary intervention (angiography and/or coronary intervention);
- •Patients with chronic renal insufficiency, the baseline estimated glomerular filtration rate (eGFR) was 15-60 mL/min / 1.73 m²
- •At least one risk factor (age>75 years, medical history of diabetes mellitus or hypertension, congestive heart failure [NYHA class >II or history of acute pulmonary edema]);
排除标准
- •End-stage renal failure or heart/renal transplantation;
- •History of exposure to contrast medium or acute infectious diseases within 48 hours prior to the procedure;
- •Acute decompensated heart failure;
- •Left ventricular thrombus;
- •Allergy to contrast agent;
- •Pregnancy or lactation;
- •Malignant tumour or life expectancy <1 year;
- •Pre-procedural receipt of NSAIDs (except Asprin), aminoglycosides, cyclosporine or cisplatin in the past 48 h;
- •Severe valve disease or elective undergoing surgery.
结局指标
主要结局
Contrast-associated acute kidney injury a
时间窗: 72 hours
Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure
次要结局
- Number of Participants with Acute heart failure(post-procedural during hospitalization, an average of 3 days)
- Major adverse clinical events(1 year)
- Length of stay(an average of 7 days)
- Contrast-associated acute kidney injury b(72 hours)
- Contrast-associated acute kidney injury d(48 hours)
- Contrast-associated acute kidney injury e(24 hours)
- Change in eGFR a(72 hours)
- Contrast-associated acute kidney injury c(24 hours)
- Contrast-induced persistence kidney injury(3 months)
- Change in eGFR b(72 hours)
- Total hospitalization costs(an average of 7 days)
研究者
Jiyan Chen
MD
Guangdong Provincial People's Hospital