Sepsis Metabolomics
2014年1月13日 更新者:Longxiang Su、Chinese PLA General Hospital
Systemic Metabolic Changes of Sepsis Patients Revealed by an LC-MS/MS Based Metabolomic Approach
The occurrence of sepsis and its relevant multiple organ dysfunction remain a major problem in intensive care units with high morbidity and mortality.
The differentiation between non-infectious and infectious etiologies, severity and organ function evaluation, and prognostic assessment are all challenging in routine clinical practice.
Many biomarkers have been suggested for these purpose; however sensitivity and specificity even of high-ranking biomarkers still remain insufficient.
Recently, metabolic profiling has attracted interest for biomarker discovery.
In this study, LC-MS/MS will be perform to identify serum metabolic biomarkers for differentiation of SIRS/sepsis, severity and organ function evaluation, and prognostic assessment among 65 patients.
The investigators enrolled 35 patients who were diagnosed with sepsis, 15 patients who were diagnosed with SIRS, and 15 normal patients.
Moreover, the sepsis were further divided into sepsis, severe sepsis, and sepsis patients before death.
Small metabolites that were present in patient serum samples were measured by LC-MS/MS techniques and analyzed using multivariate statistical methods, such as Principal Component Analysis (PCA), Partial Least Squares-Discriminant Analysis (PLS-DA), and Orthogonal Partial Least Squares Discriminant Analysis.
Based on the multivariate statistical analysis above, the investigators could distinguish sepsis from normal and SIRS; distinguish the difference among sepsis, severe sepsis and death.
We hypothesis that some metabolites as identified in this study are promising biomarker candidates in the field of sepsis diagnosis and treatment.
研究概览
研究类型
观察性的
注册 (实际的)
65
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Beijing
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Beijing、Beijing、中国、100853
- Chinese PLA General Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
All subjects were selected from among inpatients who were hospitalized between July 2010 and Mar 2012 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.
描述
Inclusion Criteria:
- male and female aged 18 years old and over;
- clinically confirmed infection;
- fulfilled at least two criteria of systemic inflammatory response syndrome
- core temperature higher than 38 °C or lower than 36 °C
- respiratory rate above 20/min, or PCO2 below 32 mmHg
- pulse rate above 90/min, and
- white blood cell count greater than 12,000/μl or lower than < 4,000/μl or less than 10% of bands.
Exclusion Criteria:
- younger than 18 years of age;
- acquired immunodeficiency syndrome;
- reduced polymorphonuclear granulocyte counts (< 500 μL-1);
- died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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爵士
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Normal control
Healthy volunteers
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sepsis
sepsis is defined as SIRS plus confirmed infection.
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severe sepsis
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death
sepsis patients within 48 hours before death.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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death
大体时间:sepsis patients within 48 hours before death
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sepsis patients within 48 hours before death
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Lixin Xie, Dr、Department of Respiratory Diseases, Chinese PLA General Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年7月1日
初级完成 (实际的)
2012年3月1日
研究完成 (实际的)
2012年3月1日
研究注册日期
首次提交
2012年7月23日
首先提交符合 QC 标准的
2012年7月24日
首次发布 (估计)
2012年7月25日
研究记录更新
最后更新发布 (估计)
2014年1月14日
上次提交的符合 QC 标准的更新
2014年1月13日
最后验证
2014年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.