Effects of Perioperative Goal-Directed Therapy Based on Individualized Oxygen Balance on Outcomes During High-risk Cardiac Surgery:A Single Center, Prospective,Randomized,Controlled,Double Blinded Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- 30-day mortality
研究概览
简要总结
Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational study suggested that the cumulative duration of a triple-low state [intraoperative low mean arterial pressure (MAP), low bispectral index (BIS), and low target effect-site concentration(Ce) ]was associated with poorer 30-day mortality.This randomized, prospective study based on individualized Oxygen dynamics is designed to confirm this association in high-risk patients cardiopulmonary bypass (CPB).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients were followed up by an investigator unaware of the patients' achievement or not of the oxygen dynamic goal
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent;
- •Selective cardiac surgery and general anesthesia patients;
- •Age 18-90 yrs;
- •Anesthesia Society of American (ASA) Scale II-IV
- •European System for Cardiac Operative Risk Evaluation score equal to or greater than 6 or left ventricular ejection fraction lower than 50%
排除标准
- •Preoperative cardiac ejection fraction<30 %;
- •History of anesthesia awareness;
- •History or anticipation of difficult intubation;
- •Unanticipated intraoperative conditions, including haemorrhage, obstinate resuscitation failure,multiple cardiopulmonary bypass procedures, severe hypotension or hypoxemia;
- •long-term preoperative use of anticonvulsant agents, opiates, benzodiazepines or cocaine.
研究组 & 干预措施
Individualized Goal-Directed Therapy
The goal of intervention:mean artery pressure declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.
干预措施: mean artery pressure (Procedure)
Individualized Goal-Directed Therapy
The goal of intervention:mean artery pressure declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.
干预措施: bispectral index (Procedure)
Individualized Goal-Directed Therapy
The goal of intervention:mean artery pressure declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.
干预措施: Brain oxygen saturation (Procedure)
Controlled
no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.
干预措施: Controlled (Other)
结局指标
主要结局
30-day mortality
时间窗: 30-day after surgery
Data for duration of postoperative 30-day all-cause mortality
Major postoperative complications(i.e., Rate of low cardiac output syndrome, stroke, myocardial ischemia, infection,reoperation, and need for dialysis)
时间窗: 30-day after surgery
Number of Participants with major complications extracted after 30-day follow-up
The change of incidence of postoperative delirium
时间窗: The 1,2,3 day after surgery
Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium
1,3,5-year mortality
时间窗: 1,3,5-year after surgery
Data for duration of 1,3,5-year all-cause mortality is extracted after 1-year follow-up
次要结局
- The change of incidence of postoperative cognition dysfunction(1 day before surgery, the 3,7 day after the surgery)
- postoperative hospital stay(30-day after surgery)
- The occurrence of cardiovascular events(30-day after surgery)
- The incidence of any adverse events(30-day after surgery)