跳至主要内容
临床试验/NCT03216850
NCT03216850已完成不适用

Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX

University Hospital Hradec Kralove1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Endothelial Glycocalyx Thickness

研究概览

简要总结

Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx.

The aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled.

Monitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients in ICU
  • indication for lipid administration as a part of TPN

排除标准

  • shock or clinical/laboratory signs of tissue hypoperfusion
  • previous lipid infusions (within 3 months before entering study)
  • hyperlipidaemia
  • hyperglycaemia (over 10 mmol/l)
  • current or previous (within 72 hours before entering the study) use of propofol
  • pancreatitis
  • severe liver failure
  • current use of statins

结局指标

主要结局

Endothelial Glycocalyx Thickness

时间窗: One week within the ICU care

Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is.

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

Vladimir Cerny

Clinical Professor

University Hospital Hradec Kralove

研究点 (1)

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