跳至主要内容
临床试验/NCT01850485
NCT01850485已完成不适用

Microcirculatory Perfusion as Measured by Sublingual SDF Imaging and NIRS in Patients With Coma After Out-of-hospital Cardiac Arrest Treated With Mild Therapeutic Hypothermia (TH) or Not Treated With Mild-TH

Medical Centre Leeuwarden1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Microvascular Flow Index (MFI)

研究概览

简要总结

The hypothesis is: In patients after an out of hospital cardiac arrest, treated with therapeutic hypothermia (33°C) will be found significantly more microcirculatory abnormalities, compared to the same group of patients treated with 36°C.

详细描述

The purpose of this study is to investigate the (sublingual) microcirculation in patients after an out of hospital cardiac arrest (OHCA). The microcirculation is measured in this study by Sublingual Side Stream Darkfield (SDF) Imaging and Near InfraRed Spectroscopy (NIRS) at admission and after 12 and 24 hours.

研究设计

研究类型
Observational
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

  • out-of-hospital cardiac arrest
  • > 18 years
  • informed consent
  • ROSC (return of spontaneous circulation) < 4 hours

排除标准

  • recent maxillofacial surgery
  • participation in other clinical trials

结局指标

主要结局

Microvascular Flow Index (MFI)

时间窗: baseline measurement

Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)

次要结局

  • Fluid Balance After 24 Hours(24 hours)
  • Inotropes and Vasopressor Dose(baseline)
  • Cardiac Index(24 hours)
  • SvO2(24 hours)
  • RincStO2(baseline)
  • Lactate(24 hours)

研究者

发起方
Medical Centre Leeuwarden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matty Koopmans

RN

Medical Centre Leeuwarden

研究点 (1)

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