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临床试验/NCT04173221
NCT04173221已完成不适用

Direct Assessment of Microcirculation In Shock (DAMIS)

Heinrich-Heine University, Duesseldorf6 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
141
试验地点
6
主要终点
mortality

研究概览

简要总结

Maintaining organ perfusion is the key to successful intensive care medicine. Shock is the most dangerous microcirculatory disorder and one of the most hazardous and lethal conditions of critically ill patients still showing high mortality rates. However, there are still ongoing controversies, how to assess microcirculation, how to predict outcome in time and how to guide specific therapy. Macrocirculation does not reflect microcirculation. Microcirculation reflects organ perfusion and correlates with the outcome. There is growing evidence that microcirculatory parameters are powerful tools to predict the outcome after cardiac arrest. Several guidelines use it as a target to guide therapy, but these recommendations base only on supporting evidence of low quality. Lactate is a late reflector of reduced organ perfusion and is of limited value for time-critical decision-making and their value as a therapeutic target. Sublingual sidestream dark-field (SDF) - measurement is a non-invasive method that reliably reflects organ perfusion. The last generation of microcirculation assessment tools are easy to use hand-held devices that use an automatic algorithm. In consequence, microcirculation has become a directly detectable physiological compartment. However, systematic investigations about this technology in shock are still lacking. DAMIS determines the value of directly assessed microcirculation on outcome in different types of shock. Therefore, this multicenter study will recruit up to 200 patients in shock. After the first measurement, patients will be randomized either to intervention or to control. The intervention consists in knowing microcirculatory parameters. A checklist will assist the treating physicians of the interventional group in explaining microcirculatory values and offering possible treatment options. Patients in the control group will be measured as well, but results will not be communicated to the treating physician.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

盲法说明

Sublingual SDF-Measurement at admission and after 24h, with or without communication and interpreting checklist to the treating physician

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

  • Older than 18 years
  • Admitted to the ICU in state of shock at the time point of admission to ICU or in the first 3 hours defined as
  • the need to use vasopressors, -dilatators, fluids to maintain mean arterial pressure > 65 mmHg
  • AND lactate > 2 mmol/l

排除标准

  • Younger than 18 years
  • Anatomic reasons that inhibit sublingual measurement
  • Lack of informed consent
  • more than 4 hours after ICU admission

结局指标

主要结局

mortality

时间窗: 30 day

relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality

次要结局

  • length of stay at ICU and hospital(90 days)
  • mortality(6 and 12 months)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (6)

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