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临床试验/NCT02430142
NCT02430142已完成不适用

Microcirculatory Oxygen Uptake in Sepsis, Severe Sepsis and Septic Shock

Universitätsmedizin Mannheim1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

Forearm vasoocclusive testing (VOT) will be performed with laser-doppler spectrophotometry system in septic patients on ICU. Microcirculatory oxygen uptake will be checked for prognostic value and for associations with tissue hypoxia markers and high central venus saturations.

详细描述

Sepsis remains a common entity in critical care patients with remarkable mortality. Microcirculatory dysfunction plays a pivotal role in the pathophysiology of sepsis and organ dysfunction. The main causal mechanisms are vasoactive substances such as nitric oxide and endothelin, destroyed endothelial surfaces and microvascular occlusion by activated coagulation and leucocytes. Furthermore there is some knowledge from vasooclussive testing (VOT) based on near-infrared spectroscopy (NIRS) and assessing the proportion of perfused vessels determined with orthogonal polarization spectral and sidestream darkfield imaging techniques (SDF) that impaired microcirculation is associated with organ dysfunction and increased mortality. Despite these well-recognised evidence previous trails proving therapy guidance with microcirculatory parameters failed in demonstrating optimised outcome . Recent guidelines still recommend fluid therapy based on central venous pressure, mean arterial pressure, urine output and or blood lactate concentration. But especially the parameter central venous oxygen saturation (ScvO2) seems to be not unproblematic. Retrospective data analysis found higher mortality rates if ScvO2 is elevated.

In the present study patients with sepsis, severe sepsis and septic shock will be evaluated on day 1 and day 4 and a follow up will be performed on day 180.

Additional to clinical parameters of organ function, infection markers, global parameters of tissue hypoxia will be captured by measurements of adenosine and whose metabolites.

Macrocirculatory cardiovascular function delivered by transpulmonary thermodilution technique will be assessed and local tissue perfusion and oxygen uptake will be measured with a transcutaneous laser-doppler spectrophotometry system in VOT.

The aim of this study is to check:

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

  • Criteria according to the SSC for sepsis, severe sepsis and septic shock
  • Admission to the ICU within 24 hours

排除标准

  • Pregnancy
  • Cardiopulmonary resuscitation within the last 5 days

结局指标

主要结局

Overall Survival

时间窗: 180 days

ICU-Mortality, 60-days-mortlity, 180-days-mortality will be recorded and correlated with baseline and postischemic microcirculatory oxygen delivery and uptake.

次要结局

  • Physical condition(180 days)
  • Connection between ScvO2 and microcirculatory oxygen uptake(Day 1 and day 4)
  • Connection between adenosine-metabolites and microcirculatory oxygen uptake(Day 1 and day 4)

研究者

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

Timo Sturm

Dr. med. Timo Sturm, DESA

Universitätsmedizin Mannheim

研究点 (1)

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