The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) Applied on Cardiac Surgery With Cardiopulmonary Bypass: a Single Center, Randomized, Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- The length of hospital stay
研究概览
简要总结
This study evaluates the enhanced recovery after surgery (ERAS) concept over conventional postoperative care in patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass. Half of participants will adherence to the ERAS, while the other half will under the conventional postoperative care.
详细描述
Enhanced recovery after surgery (ERAS) or fast-track surgery is a perioperative and postoperative care concept initiated in the early 1990s aiming to reduce the length of hospital stays following elective abdominal surgery. The success of ERAS depends highly on multidisciplinary teamwork and patient compliance.
This study intends to compare the Enhanced Recovery After Surgery (ERAS) concept applied to patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass under traditional perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an effective perioperative management during cardiopulmonary bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart function grade II - III (Using the cardiac function classification method formulated by American Heart Disease Institute)
- •The in - hospital was treated with extracorporeal circulation operation and general anesthesia.
- •Had a good cognition, and signed the informed consent.
- •Aged between 18 and
- •The age, clinical examination and other generally situation of the two groups of patients had no statistical significance.
排除标准
- •Combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease.
- •Patients with severe mental disorders cannot cooperate with the treatment.
- •Emergency operation
- •Have taboo of Echocardiography and pulmonary catheterization by echocardiography.
- •Patients have been fitted with a pacemaker.
- •Allergic to erythropoietin.
- •Suspected or had alcohol, drug abuse history.
- •Spinal deformity or paravertebral lesions.
结局指标
主要结局
The length of hospital stay
时间窗: From pre-surgery to discharge, up to 8 weeks
The postoperative hospital time
时间窗: From pre-surgery to discharge, up to 4 weeks
The time of readiness to discharge
时间窗: From pre-surgery to discharge, up to 4 weeks
Length of ICU stay
时间窗: From entering the ICU to roll out, up to 4 weeks
Hospitalization cost
时间窗: When the patient is discharged
次要结局
- C-reactive protein(baseline and 5 days after operation)
- Serum Creatinine(baseline and 5 days after operation)
- Postoperative tracheal tube time(From the end of surgery to the removal of tracheal tube, up to 4 weeks)
- Time to first bowel movement(From the end of surgery to first exhaust, up to 2 weeks)
- Hemoglobin(baseline and 5 days after operation)
- Troponin I(baseline and 5 days after operation)
- Perioperative major adverse events(From pre-surgery to discharge, up to 4 weeks)
- Procalcitonin(baseline and 5 days after operation)
- Duration of mechanical ventilation after surgery(From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks)
- Postoperative time to first exhaust(From the end of surgery to first exhaust, up to 2 weeks)
- Erythrocyte Sedimentation Rate(baseline and 5 days after operation)
- Vasoactive drugs Support Hours(From the start of drugs to stop them, up to 4 weeks)
- N-terminal B-type natriuretic peptide（NT-proBNP)(baseline and 5 days after operation)