Cerebral Near-Infrared Spectroscopy Monitoring in High-Risk Cardiac Surgery Patients: A Prospective, Randomised, Single-Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence of postoperative complications
研究概览
简要总结
Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.
Hypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.
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
- Single (Participant)
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
- •High-risk cardiac surgery patients as determined by at least one of the followings:
- •the age greater than or equal to 75 years on the day of screening;
- •left ventricle ejection fraction less than 35%;
- •use of a preoperative intraaortic balloon pump;
- •combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance < 60 ml/min)
排除标准
- •refusal of consent
结局指标
主要结局
Incidence of postoperative complications
时间窗: Up to 30 day after randomisation
This composite outcome includes: myocardial infarction, stroke, delirium, postoperative cognitive dysfunction, wound infection, mediastinitis, mechanical ventilation more than 24 h, arrhythmia, reoperation for bleeding, acute kidney injury, and acute kidney injury requiring dialysis.
次要结局
- Duration of postoperative hospital stay(Up to 30 day after randomization)
- Incidence of major organ morbidity and mortality(Up to 30 day after randomization)
- Death from all causes at 30 days(Up to 30 day after randomisation)
- Duration of intensive care unit stay(Up to 30 day after randomization)
研究者
Evgeny Fominskiy, MD, PhD
Mr
Meshalkin Research Institute of Pathology of Circulation