Patient Management During Major Abdominal Surgery: the Impact of a Hemodynamic Approach Oriented to Oxygen Consumption Optimization Compared to Standard Approach Targeting Preload-dependency and a Clinically-guided Strategy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Perioperative fluid balance
研究概览
简要总结
This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged > 18 years
- •acquisition of written informed consent
- •Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours
排除标准
- •Absolute contraindication to CVC placement
- •pregnant women
- •hepatic surgery
- •laparoscopic surgery
- •Major vascular surgery
- •Dialysis treatment and kidney transplant surgery
- •Severe heart failure (EF ≤ 35%)
- •Emergency surgery
结局指标
主要结局
Perioperative fluid balance
时间窗: surgery
Perioperative fluid balance
次要结局
- Post-operative complication(1 day (Hospital discharge))
- Survival at 28 days(28 days after surgery)
- Survival at hospital discharge(1 day (Hospital discharge))
研究者
Antonio Maria Dell'Anna
MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
