A Clinical Study on the Application of Enhanced Recovery After Surgery for Simultaneous Pancreas-kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Length of hospital stay (LoS)
研究概览
简要总结
108 patients underwent elective SPK surgery were randomly divided into ERAS group (E) and routine care group (T). The ERAS group was consisted of evidenced-based systematic optimization approaches, while the control group received routine care.
详细描述
Primary results: the postoperative length of stay (LoS) and hospitalization costs; second results: post-operative analgesia score (NRS) , the incidence of post-operative nausea and vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube indwelling time, the incidence of ambulation within 6 days . the dosage of dobutamine using , the dosage of norepinephrine using, and the total amount of fluid and urine volume . MAP and lactate level . Peak systolic velocity (PSV) and (resistance index) RI of grafts were checked between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were aged 20-62 years
- •Body mass index (BMI) of 18.5-32.9 kg/m2
- •Voluntary participation for elective SPK surgery
- •ERSD and DN patients waiting for SPK transplantation surgery.
排除标准
- •History of allergy to narcotic drugs
- •cardiopulmonary insufficiency
- •congestive heart failure
- •myasthenia gravis
- •neurological disease
- •mental illness
- •severe liver dysfunction
- •hyperkalaemia
- •malignant hyperthermia
- •unwilling to participate in the study for any reason, or had participated in another study within the 3 months
结局指标
主要结局
Length of hospital stay (LoS)
时间窗: Record all the period time from the day of admiting to hospital to the day of discharge from hospital(days).
Record the time for SPK recipients of LoS (days)
Hospital costs (US dollar)
时间窗: Total costs(dollar) of the patients spended from the day of admiting to hospital to the day of discharge from hospital(days).
The total cost of treatment for the patients.
次要结局
- Perioperative complications(After the surgery acomplishment(see detail above)：record the NRS within 40hours after the surgery, occurrence rate of the PPCs within 2 weeks after the surgery, ocurrence rate of the ambulation within 6 days after the surgery, etc.)