Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- different hemodynamic fluid responses in the different groups
研究概览
简要总结
Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.
详细描述
To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI <25) vs. obese patients (BMI >25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)
排除标准
- •cardiac insufficiency (EF< 35%)
- •renal insufficiency (creatinin clearance <30ml/min, dialysis)
- •insulin dependant diabetes mellitus
- •coagulopathy
- •infection
- •history of suspect malignant hyperthermia
- •porphyria
研究组 & 干预措施
Ringerlactate lean
fluidtherapy with crystalloids in lean patients
干预措施: fluidotherapy with ringer-lactate (Drug)
Ringerlactate overweight
fluidtherapy with crystalloids in overweight patients
干预措施: fluidotherapy with ringer-lactate (Drug)
Ringerlactate obese
fluidtherapy with crystalloids in obese patients
干预措施: fluidotherapy with ringer-lactate (Drug)
结局指标
主要结局
different hemodynamic fluid responses in the different groups
时间窗: every 10 minutes during surgery
次要结局
- Subcutaneous oxygen tension (PsqO2)(every 10 minutes during surgery and 2 hours postoperatively)
研究者
Andrea Holzer
MD
Medical University of Vienna