Effect of Hydration Guided by Vigileo on the Prevention of Contrast Induced Nephropathy After Emergency PCI for Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Contrast induced nephropathy
研究概览
简要总结
In this study, Vigileo is used to guide hydration adjustment, and SCr is used to estimate renal function. The aim of the study is to investigate the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy in patients with acute myocardial infarction who undergo PCI.
详细描述
This study was conducted in patients with acute myocardial infarction who undergo emergency PCI in Chinese PLA General Hospital. The patients were randomly divided into two groups: the adequate hydration group guided by Vigileo and control group. For the adequate hydration group guided by Vigileo, Vigileo equipment is used to perform hemodynamic monitoring through the femoral or radial arteries to obtain relevant hemodynamic parameters (CO, SV, SVV), and the fluid-rehydration velocity of normal saline is adjusted according to the hemodynamic parameters, and the hydration also lasts 24 hours after operation. For the control group, the routine hydration regimen is adopted, perioperative saline ≤500 ml hydration. The changes of renal function (serum creatinine, serum cystatin), symptoms and signs of cardiac insufficiency during perioperative period and cardiac objective indexes are observed. The incidence of postoperative acute pulmonary edema is recorded, and the major cardiovascular events and hemodialysis events are followed up for 6 months. By comparing the perioperative indexes of heart and kidney function between the intervention group and the control group, the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy after PCI was clarified.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clearly diagnosed STEMI or NSTEMI patients:
- •Patients aged 18-80 years
- •Patients are scheduled to undergo emergency percutaneous coronary interventions
- •Estimated glomerular filtration rate eGFR <120ml / min (according to MDRD formula)
- •Sign the informed consent to join the group.
排除标准
- •Patients with mechanical complications
- •Patients with cardiogenic shock
- •Patients with aortic dissection
- •Patients who have malignant tumors or short-term progressive diseases that researchers believe improper to be included in the group
- •Hemodialysis-dependent patients with end-stage renal failure
- •Patients who had a history of exposure to radioactive contrast media within 1 week before or 72 hours after direct PCI
- •Patients who are allergic to radioactive contrast agents
- •Patients diagnosed with right ventricular myocardial infarction with hypotension (defined as systolic blood pressure ≤90 mmHg) on admission.
研究组 & 干预措施
the adequate hydration group guided by Vigileo
The hydration speed is adjusted according to SVV or SV by Vigileo
干预措施: the adequate hydration group guided by Vigileo (Procedure)
the control group
The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration
结局指标
主要结局
Contrast induced nephropathy
时间窗: 48-72 hours after PCI
Contrast induced nephropathy is defined as serum creatinine values increased by 0.5 mg/dl or 25% relative to baseline absolute values after direct PCI within 48-72 hours.
次要结局
- The acute renal injury caused by contrast agent(48 hours after PCI)
- Major adverse cardiac events(6 months after PCI)
- renal replacement therapy and/or death from acute renal failure(6 months after PCI)
- Persistent renal insufficiency(3 months after PCI)
研究者
Qian geng
Clinical Professor
Chinese PLA General Hospital