跳至主要内容
临床试验/NCT01503684
NCT01503684Unknown不适用

Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Development and severity of sepsis

研究概览

简要总结

In this proposal, the investigators wish to investigate, identify and validate potential biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.

详细描述

In this proposed project, we will focus on the identification of potential biomarkers in EBC with ability to predict development of multi-organ failure. Currently, no tools could be used to evaluate the effect of mitochondrial dysfunction in sepsis. All the human studies discussing mitochondrial dysfunction in sepsis use tissue biopsies as study materials. Repeated tissue biopsy is invasive and not applicable. EBC could be collected non-invasively and conveniently. A study has demonstrated the use of metabolomic technologies in mitochondrial diseases. We believe that the metabolomic biomarkers of EBC could be used to demonstrate mitochondrial dysfunction in lungs and respiratory tracts of septic patients. Such metabolomic biomarkers may also reflect similar on-going mitochondrial dysfunction in other organ systems, and could potentially become a novel diagnostic tool and a therapeutic target in future sepsis therapy.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • above 20 years old
  • admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube

排除标准

  • active malignancy
  • in an immunosuppressed status such as HIV disease, neutropenia, being treated with immunosuppressive agents
  • expected to have an unavoidable very short life expectancy after admission, i.e., < 3 days

结局指标

主要结局

Development and severity of sepsis

时间窗: 28 days

To record APACHE II, SOFA, and MODS, etc.

次要结局

  • Response to treatment and progression of organ failure(28 days)
  • Mortality(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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