Clinical Study on Tailored Hydration by Remote Dielectric Sensing System to Prevent Acute Renal Injury in Elderly Patients With Renal Insufficiency After Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Contrast induced acute kidney injury
研究概览
简要总结
Explore the effectiveness and safety of tailored hydration guided by lung water index monitor system for prevention of acute kidney injury after percutaneous coronary intervention for elderly patients with renal insufficiency.
详细描述
The elderly patients with coronary heart disease is often complicated with chronic kidney disease, and these high risk patients has a risk of developing contrast induced acute kidney injury after undergoing percutaneous coronary intervention. Hydration is an important prevention to reduce the risk of contrast induced acute kidney injury , but hydration may cause acute left heart failure in elderly patients with renal insufficiency. We designed to give the elderly patients necessary hydration volume to reduce the risk of contrast induced acute kidney injury, and meanwhile avoid acute pulmonary edema caused by excessive preload. This study aimed to explore tailored hydration guided by lung water monitoring to prevent contrast induced acute kidney in elderly patients with renal insufficiency undergoing percutaneous coronary intervention. This study randomly divided elderly patients who are planning to undergo coronary intervention into two groups: tailored hydration group guided by remote dielectric sensing (ReDS system) and control group. The intervention group uses ReDS system to dynamically monitor the lung water index of enrolled patient, and fluid infusion rate is dynamically adjusted by lung water index to prevent the occurrence of acute pulmonary edema. We plan to evaluate the occurrence of postoperative acute kidney injury and acute pulmonary edema in two groups during the perioperative period. We follow up both major cardiovascular events and hemodialysis events in two groups.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years;
- •Patients with unstable angina pectoris are scheduled for percutaneous coronary intervention；
- •Patients with chronic renal disease (estimated glomerular filtration rate < 90 ml/min);
- •Sign the informed consent form.
排除标准
- •1. Acute decompensated severe heart failure or cardiogenic shock;
- •2. Malignant tumors, severe renal failure (estimated glomerular filtration rate < 30 ml/min);
- •3. Respiratory failure;
- •4. Used contrast media within one week;
- •5. Have allergic to contrast medium
研究组 & 干预措施
Tailored hydration guided by ReDS system
The group guided by lung water monitor adjust hydration infusion rate dynamically adjusts based on the lung water parameters from the ReDS system.
干预措施: Tailored hydration guided by ReDS system (Procedure)
Cntrol group
The control group performs the conventional hydration recommended by guidelines: administering normal saline at a rate of 1 ml/kg/h from 6 hours before procedure to 12 hours after procedure.
结局指标
主要结局
Contrast induced acute kidney injury
时间窗: 3 days after procedure
Increase in the creatinine level of at least 0.5 mg/dl (44 μmo/L) or at least a 25% increase from the baseline level within 2 to 3 days after PCI
次要结局
- Acute kidney injury(2 days after procedure)
- Acute pulmonary edema(7 days after procedure)
- Renal replacement therapy(12 months after procedure)
- Persistent renal insufficiency(3 months after procedure)
- Cardiovascular adverse events(12 months after procedure)
研究者
Qian geng
MD
Chinese PLA General Hospital