Endotoxin Activity Assay and Microcirculation in Severe Sepsis
2015年12月17日 更新者:National Taiwan University Hospital
Endotoxin Activity Assay and Microcirculation Examination in Patients With Severe Sepsis
Endotoxin is the major mediator of sepsis resulted from systemic inflammatory response syndrome induced by gram-negative bacteria infection.
The endotoxin related inflammatory response and hypercoagulation can result in microcirculatory dysfunction.
When microcirculatory dysfunction is severe, it can induce multiple organ dysfunction syndrome and death.
This is a prospective observational study, and it will not influence the sepsis treatment decision of the medical care team.
The critically ill severe sepsis patients will be enrolled only if they meet all inclusion criteria, do not meet any exclusion criteria and sign the consent form after explanation of the aim and process of the trial by the primary investigator or research personnel.
After enrollment, the patient will receive serum assay of endotoxin activity (EAA) and endocan level.
The patient will also receive examination of sublingual microcirculation by using the incident dark field video microscope.
After 24 hours, the patient will receive assay of endocan level and examination of sublingual microcirculation.
This study will record the vital signs, laboratory data, dose of vasopressors and inotropic agents, and severity of organ dysfunction.
After 28 days, this study will check the survival, stay of intensive care, stay of hospital, ventilator day, and the results of culture of pathogens.
The patients will be assign to the following three groups by the EAA level: low EAA group (< 0.40 EAA units); intermediate EAA group (0.40-0.59 EAA units); and high EAA group (≧ 0.60 EAA units).
This grouping will be used for statistical analysis and comparison.
The primary goal of this study is to investigate the difference of the prevalence of gram-negative bacteria infection, pathogen, infection source, microcirculation, the severity of disease, and the prognosis among these three groups.
研究概览
研究类型
观察性的
注册 (预期的)
100
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。
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
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with severe sepsis
描述
Inclusion Criteria:
- patients with the following infections: intraabdominal infection, pneumonia, urinary tract infection, blood stream infection, or wound infection
patients must also meet any one of the following criteria for severe sepsis
- SBP < 90 mm Hg, MAP < 65 mm Hg, or requirement of vasopressors or inotropics
- PaO2/FiO2 < 300
- Creatinine level > 2 mg/dL or increase > 0.5 mg/dL; or urine output < 0.5 mL/kg/h more than 2 hours
- Bilirubin level > 4 mg/dL
- Platelet count < 100 k/uL or decrease more than 50%
- INR > 1.5 or aPTT > 60 sec
- GCS < 13 or 9T
- Lactate > 2 mmol/L (with pH < 7.3 or base excess < -5 mmol/L)
Exclusion Criteria:
- younger than 20 yeras old or greater than 99 years old
- the onset of severe sepsis before enrollment is greater than 24 hours
- pregnant
- have received plymyxin-B hemoperfusion within 24 hours before enrollment
- non-native speaker
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 |
干预/治疗 |
---|---|
Low EAA
Endotoxin Activity Assay [EAA] level < 0.40 EAA units
|
|
Intermediate EAA
Endotoxin Activity Assay [EAA] level between 0.40-0.59
EAA units
|
|
High EAA
Endotoxin Activity Assay [EAA] level >= 0.60 EAA units
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Difference of the prevalence of gram-negative bacteria infection
大体时间:At enrollment
|
Compare the prevalnce of gram-negative bacteria infection among the three groups
|
At enrollment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
28天死亡率
大体时间:28天
|
28天
|
|
Difference of Total small vessel density
大体时间:At Enrollment
|
Total small vessel density will be measured by incident dark field video microscope.
Compare the difference among the three groups.
|
At Enrollment
|
Difference of Perfused small vessel density
大体时间:At enrollment
|
Perfused small vessel density will be measured by incident dark field video microscope.
Compare the difference among the three groups.
|
At enrollment
|
Endocan level
大体时间:At enrollment
|
Endocan level will be measured by Human Endocan kit.
Compare the difference among the three groups.
|
At enrollment
|
SOFA score
大体时间:At enrollement
|
Compare the Sequential Organ Failure Assessment score among the three groups
|
At enrollement
|
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。
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
2016年1月1日
初级完成 (预期的)
2017年5月1日
研究完成 (预期的)
2017年6月1日
研究注册日期
首次提交
2015年5月20日
首先提交符合 QC 标准的
2015年5月20日
首次发布 (估计)
2015年5月22日
研究记录更新
最后更新发布 (估计)
2015年12月18日
上次提交的符合 QC 标准的更新
2015年12月17日
最后验证
2015年12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.
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