A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 10
- 主要终点
- incidence of postoperative ileus (POI)
研究概览
简要总结
The purpose of this study is to help us learn what is the best amount of fluid to give to patients during bladder surgery in order to avoid delayed bowel function after surgery, which could prolong 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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (21 years old or greater) who are able to provide informed consent
- •Patients who undergo an open, elective radical cystectomy
排除标准
- •Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia
- •Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery)
- •Presence of ascites, because increased abdominal pressure interferes with EV1000 reading accuracy
- •BMI > 45 or <17, because increased abdominal pressure interferes with EV1000 reading accuracy
研究组 & 干预措施
Standard fluid management
The non-intervention group will receive maintenance crystalloid fluid at 10cc/kg/h. Blood loss will be replaced 1:1 with albumin. Transfusion will follow transfusion criteria. Fluid management will not be dependent on the EV1000
干预措施: standard fluid management (Other)
Goal directed fluid therapy (GDT)
In the GDT arm, patient's SV will be optimized before induction with crystalloid boluses prior to induction of general anesthesia. The GDT arm will have fluid therapy guided by the Edwards EV1000-clinical platform and maintenance crystalloid fluid will be 3cc/kg/h. During the surgical procedure when SVV rises above 12 an albumin bolus will be administered at 250 ml increments until the SVV falls below 8. Transfusion will follow transfusion criteria.
干预措施: fluid management guided by the EV1000 (Other)
结局指标
主要结局
incidence of postoperative ileus (POI)
时间窗: 3 years
POI will be defined as intolerance of oral intake by postoperative day 5, or the cessation of diet and/or placement of an NGT for clinical signs or symptoms associated with POI, including one or more of the following: nausea, emesis, abdominal bloating or distension, or excessive burping. Rate of ileus will be compared between the treatment groups using the chi-square test. A 95% confidence interval for the difference in ileus rate will also be reported.
次要结局
- compare total volume of fluid(the first 72 hours)
- complications(1 year post operatively)