跳至主要内容
临床试验/NCT03113435
NCT03113435招募中不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
76
试验地点
1
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

研究组 & 干预措施

Standard

No Intervention

In this group standard care will be provided to patients undergoing major abdominal surgery, regarding hemodynamic optimization

NICE group

Active Comparator

In this arm patients will be treated according to stroke volume optimization described in NICE program

干预措施: Oxygen consumption optimization (Other)

Oxygen consumption group

Experimental

In this arm patients will receive hemodynamic optimization based on their oxygen consumption need

干预措施: Oxygen consumption optimization (Other)

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Maria Dell'Anna

MD

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

Loading locations...

相似试验