Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 主要终点
- postoperative complications
研究概览
简要总结
This study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost.
This is an observational study followed cohort study design, due to the two therapies were not randomized assigned to the two cohorts. The details are described as follow.
详细描述
The study will be conducted in patients undergoing either elective laparotomy of gynecological malignancies or elective major orthopaedic surgery under prone position in Peking Union Medical College Hospital. The study included two stages.
In the first stage, one cohort of 300 participants with conventional fluid therapy will be involved, in which 150 patients will be selected with laparotomy of gynecological malignancies and150 patients will be selected with orthopedic surgery. All the participants in this stage will follow conventional fluid therapy to direct the amount of intraoperative fluid. Specifically, the fluid will be administered based on the principle crystalloid solution (colloid solution =2-3:1). The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. It is a standard procedure in Peking Union Medical College Hospital. Then, the incidence of postoperative complications of each group will be recorded. In addition, sample size will be estimated based on above study's results (estimated 100 participants).
In the second stage, goal-directed therapy will be applied to another cohort of 300 participants, in which 150 patients undergoing laparotomy of gynecological malignancies and 150 patients undergoing orthopedic surgery. Specifically, the fluid will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. The incidence of postoperative complications of each group will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving elective laparotomy of gynecological malignancies (LGM): including cytoreductive surgery of ovarian cancer, radical hysterectomy and staging surgery of endometrial cancer ;
- •Major elective orthopedic surgery (OS): including spinal surgery, revision surgery of hip joints ;
- •Age ≥18 years, American Society of Anesthesiologists physical status I ～IV;
- •No arrhythmia;
- •Receiving general anesthesia;
- •Requiring monitoring of direct blood pressure due to the comorbidities of patients and the nature of surgical procedures.
排除标准
- •Emergent surgery;
- •Patients with aortic regurgitation;
- •Patients with aortic stenosis, peripheral arterial diseases or other diseases contradicting to arterial canalizations;
- •Patients with mental disorders or low intelligence quotient; patients who cannot cooperate or refuse to sign the consent.
结局指标
主要结局
postoperative complications
时间窗: 30 days after the surgery
the incidence of complications related to surgeries 30 days postoperatively. The complications include pneumonia, pulmonary embolism, cardiovascular events (myocardial infarction, heart failure), wound infection, gastrointestinal bleeding,nausea and vomitting，postoperative hemorrhage, ileus, deep venous thrombosis, cerebral infarction, cerebral embolism, cerebral hemorrhage, renal insufficiency and failure. Those complications are defined strictly to the reference published in 2009 New England Journal of Medicine （N Engl J Med. 2009 Oct 1;361:1368-75）
次要结局
- hospital length of stay(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- hospital expenses(30 days after the surgery)
研究者
Huang YuGuang
Professor，Chairman
Peking Union Medical College Hospital