The Effect of Goal-directed Hemodynamic Therapy on Clinical Outcomes in Patients Undergoing Radical Cystectomy: : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- A composite of postoperative complications
研究概览
简要总结
Goal-directed therapy (GDT) has been applied to various clinical settings and has been widely researched recently as a method for perioperative management of patients. Radical cystectomy is a complex surgical procedure in which the bladder is removed, followed by urinary diversion. It is an extensive and time-consuming intervention and has high probability of fluid imbalance and bleeding during surgery. We hypothesized that the application of GDT in these patients would improve clinical postoperative outcomes. Therefore, we will attempt to evaluate improvement of postoperative outcomes after applying GDT protocol based on changes in stroke volume index, cardiac index and mean arterial pressure in radical cystectomy.
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)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing open radical cystectomy
- •Patients with American Society of Anesthesiologists physical status I-III
排除标准
- •Significant hepatic dysfunction, significant renal dysfunction (estimated glomerular filtration rate <60 ml/min)
- •Congestive heart failure (New York Heart Association scores ≥3), Left Ventricular Ejection Fraction < 35%
- •Arrhythmia
- •Coagulopathy (PT INR >1.5)
结局指标
主要结局
A composite of postoperative complications
时间窗: through the hospitalization period, an average of 2 weeks
Total incidence of postoperative complications including gastrointestinal complications, complications of infections, wound complications, cardiac events, thromboembolic complications, genitourinary complications, neurological complications based on the Clavien-Dindo classification for radical cystectomy.
次要结局
- The incidence of postoperative neurological complications(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative genitourinary complications(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative wound complications(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative gastrointestinal complications(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative complications of infections(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative cardiac events(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative thromboembolic complications(through the hospitalization period, an average of 2 weeks)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital