NCT04642274已完成不适用
The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis
Shanghai Zhongshan Hospital6 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Length of hospital stay
研究概览
简要总结
The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery.
详细描述
The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery, thereby improving the overall prognosis of cardiac surgery patients, reducing the incidence of complications, and shortening the length of hospital stay.
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
- Double (Investigator, 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
- •Age between 18 and 80 years.
- •Undergoing elective surgery.
- •Scheduled for cardiac valve surgery with cardiopulmonary bypass.
- •Body mass index (BMI) between 16.5 and 31 kg/m².
- •American Society of Anesthesiologists (ASA) physical status classification of II or III.
排除标准
- •Refusal to participate, refusal to sign the informed consent form, or inability to communicate.
- •Participation in other clinical trials concurrently.
- •Combined coronary artery bypass grafting or ascending aorta surgery.
- •Emergency surgery.
- •Active infective endocarditis.
- •Previous history of cardiac surgery.
- •Preoperative presence of neurocognitive disorders (NCD), depression, or other psychiatric conditions.
- •Known abuse of alcohol, drugs, or anesthetics.
- •Pregnant or breastfeeding women.
- •Presence of other serious comorbidities that may impede enrollment or affect survival, such as malignancies or severe disabilities.
- •Termination of Intervention
- •Intervention will be terminated for the following reasons:
- •Withdrawal of consent and request to exit the trial during the study period.
- •Significant changes in surgical approach: including the addition of deep hypothermic circulatory arrest, intra-aortic balloon counterpulsation (IABP) support, extracorporeal membrane oxygenation (ECMO) support, etc.
- •Medical necessity for termination of intervention, as determined by the investigator, for example: use of cardiopulmonary bypass more than twice during surgery; unexpected difficulties in weaning from cardiopulmonary bypass or extubation; continued treatment may pose a risk to the patient.
结局指标
主要结局
Length of hospital stay
时间窗: Within 1 month after surgery
次要结局
- Duration of mechanical ventilation after surgery(Within 1 week after surgery)
- Length of ICU stay(Within 1 month after surgery)
- Overall hospitalization costs(Within 3 months after surgery)
- Length of ICU stay(Within 1 month after surgery)
- Duration of mechanical ventilation after surgery(Within 1 week after surgery)
- Postoperative bowel motility(within 1 month after surgery)
- Overall hospitalization costs(Within 3 months after surgery)
- Transfusion requirements(within 1 month after surgery)
- Postoperative acute pain(within 1 month after surgery)
- Quality of recovery(within 1 month after surgery)
- Chronic pain(within 6 months after surgery)
- Patient's subjective comfort(within 6 months after surgery)
- Postoperative complications(within 6 months after surgery)
研究者
研究点 (6)
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