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临床试验/NCT05606536
NCT05606536招募中不适用

The Impact of Intra-operative Fluid Infusion Rate on Hemodilution and Microcirculation Prospective Observational Pilot Study

University Hospital Hradec Kralove1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Sublingual microcirculation profile

研究概览

简要总结

Intraoperative fluid therapy (IFT) is an integral part of anesthesia care during surgery. Its main indication is the optimization of oxygen supply to the tissues. For elective surgery that is not associated with higher blood loss and a long period of preoperative fasting, including fluids IFT is dosed to cover the basal daily need for fluids. However, it is not clear whether this fluid dose is optimal. Surgery is a stress factor that leads, among other things, to damage of the endothelial glycocalyx (EG). EG binds a significant amount of plasma, which is released during EG destruction and causes relative hemodilution.

Isovolumic hemodilution is an established intraoperative procedure that serves to better control bleeding in procedures where bleeding is expected. However, partial hemodilution occurs even with standard IFT, and even when fluids are hardly given at all. Flow parameters in microcirculation have not yet been described depending on IFT conduction. The parameters of the microcirculation reflect its functioning, which will consequently affect the postoperative phase of the patient's moaning and clinical outcome.

详细描述

Intraoperative fluid therapy (IFT) is an integral part of anesthesia care during surgery. Its main indication is the optimization of oxygen supply to the tissues. IFT is tailored to the surgical performance, blood loss, and patient (comorbidities, length of preoperative fasting, hydration level, volemia status). For elective surgery that is not associated with higher blood loss (< 200 ml) and a long period of preoperative fasting, including fluids (fluids per os < 2 hours before the procedure), IFT is dosed to cover the basal daily need for fluids (approx. 1-2 ml) /kg.hour-1). However, it is not clear whether this fluid intake is optimal. Surgery is a stress factor that leads, among other things, to damage of the endothelial glycocalyx (EG), which is a thin carbohydrate layer on the endoluminal side of endothelial cells, which is of fundamental importance for the physiology of microcirculation and tissue metabolism. EG also binds a significant amount of plasma (estimated up to 1.7 liters), which is released during EG destruction and causes relative hemodilution.

Isovolumic hemodilution is an established intraoperative procedure that serves to better control bleeding in procedures where bleeding is expected (e.g. cardiac surgery using an extracorporeal circuit or vascular surgery). However, partial hemodilution occurs even with standard IFT, and even when fluids are hardly given at all. Flow parameters in microcirculation have not yet been described depending on IFT conduction. The parameters of the microcirculation reflect its functioning, which will consequently affect the postoperative phase of the patient's moaning and clinical outcome.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective recumbent and laparoscopic surgery
  • informed consent

排除标准

  • blood loss over 250 ml
  • hemodynamic instability requiring noradrenaline infusion

研究组 & 干预措施

10 % hemodilution

Experimental

Recumbent surgery:

  • infusion rate in first 20 minutes: 15 ml/kg/h
  • infusion rate after 20 minutes: 2,6 ml/kg/h

Laparoscopic surgery:

  • infusion rate in first 20 minutes: 16 ml/kg/h
  • infusion rate after 20 minutes: 0,8 ml/kg/h

干预措施: Crystalloid Solutions (Drug)

20 % hemodilution

Experimental

Recumbent surgery:

  • infusion rate in first 20 minutes: 26 ml/kg/h
  • infusion rate after 20 minutes: 3,4 ml/kg/h

Laparoscopic surgery:

  • infusion rate in first 20 minutes: 28 ml/kg/h
  • infusion rate after 20 minutes: 1,6 ml/kg/h

干预措施: Crystalloid Solutions (Drug)

30 % hemodilution

Experimental

Recumbent surgery:

  • infusion rate in first 20 minutes: 38 ml/kg/h
  • infusion rate after 20 minutes: 5,1 ml/kg/h

Laparoscopic surgery:

  • infusion rate in first 20 minutes: 44 ml/kg/h
  • infusion rate after 20 minutes: 2,4 ml/kg/h

干预措施: Crystalloid Solutions (Drug)

结局指标

主要结局

Sublingual microcirculation profile

时间窗: 1 hour

During one hour four measurements each 20 minutes will take place. Recordings will be assessed automatically by specialised software. Microcirculatory parameters of interest are: capillary density, De Backer score, perfused capillary density and proportion of perfused vessels. Capillary density comes in mm/mm2 and the higher number the better, there is not approved median number. De Backer score is derived from capillary density and it is without dimension. Perfused capillary density signifies a percent of perfused vessels and it is in %. Normal values in healthy adults are around 90 %.

次要结局

未报告次要终点

研究者

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

David Astapenko, MD, PhD

Deputy Head for Science and Research

University Hospital Hradec Kralove

研究点 (1)

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