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临床试验/NCT04644926
NCT04644926已完成1 期

Effects of Remote Ischemic Conditioning on Microcirculatory Alterations in Patients With Sepsis

Lithuanian University of Health Sciences2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
26
试验地点
2
主要终点
Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)

研究概览

简要总结

This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis.

详细描述

This prospective open-label trial is performed in mixed ICU in a tertiary teaching hospital. Investigators include patients with sepsis or septic shock within the first 24 h after ICU admission. Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes. RIC is performed at inclusion and repeated 12 h and 24 h later. Sublingual microcirculatory measurements are obtained before and after each RIC procedure, using incidence dark field (IDF) device.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Patients with sepsis or septic shock within the first 24 h after ICU admission.

排除标准

  • age < 18 years,
  • pregnancy,
  • advanced malignancy,
  • peripheral artery disease affecting both arms,
  • oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.

结局指标

主要结局

Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)

时间窗: 30 minutes

The differences in MFI and PPV between pre- and post-RIC performance.

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

Andrius Pranskunas

professor

Lithuanian University of Health Sciences

研究点 (2)

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