TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study (TRACES)
2021年4月8日 更新者：Assistance Publique - Hôpitaux de Paris
Dysfunction and Endothelial Repair in Sepsis Shock : RNAseq Transcriptomic Analysis of Circulating Endothelial Cells
Vascular dysfunction is an important mechanism involved in organ failure, in the setting of sepsis condition, with different types of circulating endothelial cells.Transcriptom analysis via RNAseq in different types of circulating endothelial cells, comapring critically ill patients with or without sepsis will allow determining differential gene expression for signal pathways in endothelial alteration and restoration associated with sepsis.
研究概览
研究类型
观察性的
注册 (预期的)
1000
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。
学习联系方式
- 姓名：Lara Zafrani, MD PhD
- 电话号码：+33 1 42 49 94 19
- 邮箱：lara.zafrani@aphp.fr
学习地点
-
-
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Paris、法国、75010
- AP-HP Hôpital Saint Louis
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接触：
- Lara Zafrani, MD PhD
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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 至 85年 (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
Critically ill adult patients hospitalized in an intensive care unit, with or without sepsis.
描述
Inclusion Criteria:
- Age between 18 and 85 years
- Admission in intensive care with or without sepsis
- Health insurance as per the national insurance system
- Informed and unopposed patient for participation (or referend closed one)
Exclusion Criteria:
- Patient under legal protection
- Patient under national medical help system
- Pregnancy
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 |
|---|---|
|
Critically ill patients with sepsis
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Observational study.
Groups are defined based on baseline patients' characteristics : presence or absence of sepsis.
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Critically ill patients without sepsis
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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 |
|---|---|---|
|
Gene expression based on transcriptom analysis of circulating endothelial cells
大体时间：Day 1
|
Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq)
|
Day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Counts of circulating endothelial cells
大体时间：Day 1 and Day 3
|
Counts of circulating endothelial cells, including progenitor cells
|
Day 1 and Day 3
|
|
Sequential Organ Failure Assessment (SOFA) score
大体时间：Day 1, Day 3, Day 7
|
Sequential Organ Failure Assessment (SOFA) score, ranging from 0 (best: absence of organ failure) to 24 (worse: multiple organ failure)
|
Day 1, Day 3, Day 7
|
|
Sequential Organ Failure Assessment (SOFA) hemodynamic sub-score
大体时间：Day 1, Day 3, Day 7
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Sequential Organ Failure Assessment (SOFA) hemodynamic sub-score, ranging from 0 (best: absence of hemodynamic failure) to 4 (worse: hemodynamic failure)
|
Day 1, Day 3, Day 7
|
|
Sequential Organ Failure Assessment (SOFA) respiratory sub-score
大体时间：Day 1, Day 3, Day 7
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Sequential Organ Failure Assessment (SOFA) respiratory sub-score, ranging from 0 (best: absence of respiratory failure) to 4 (worse: respiratory failure)
|
Day 1, Day 3, Day 7
|
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Sequential Organ Failure Assessment (SOFA) neurological sub-score
大体时间：Day 1, Day 3, Day 7
|
Sequential Organ Failure Assessment (SOFA) neurological sub-score, ranging from 0 (best: absence of neurological failure) to 4 (worse: neurological failure)
|
Day 1, Day 3, Day 7
|
|
Sequential Organ Failure Assessment (SOFA) hematological sub-score
大体时间：Day 1, Day 3, Day 7
|
Sequential Organ Failure Assessment (SOFA) hematological sub-score, ranging from 0 (best: absence of hematological failure) to 4 (worse: hematological failure)
|
Day 1, Day 3, Day 7
|
|
Intensive care unit (ICU) mortality
大体时间：ICU length of stay
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Death during ICU stay
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ICU length of stay
|
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D28 mortality
大体时间：Day 28
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Death within 28 days of intensive care unit
|
Day 28
|
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Hospital mortality
大体时间：Day 90
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Death within 90 days of intensive care unit
|
Day 90
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Duration of ventilation
大体时间：Day 28
|
Number of days alive without ventilation up to Day 28
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Day 28
|
|
Duration of renal replacement therapy (RRT)
大体时间：Day 28
|
Number of days alive without RRT up to Day 28
|
Day 28
|
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Duration of vasopressors therapy
大体时间：Day 28
|
Number of days alive without vasopressors up to Day 28
|
Day 28
|
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Dose of vasopressors
大体时间：ICU length of stay, assessed up to 90 days
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Dose of vasopressors, in patients who received vasopressors
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ICU length of stay, assessed up to 90 days
|
|
Duration of intensive care unit (ICU) stay
大体时间：Day 28
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Number of days alive outside the ICU up to D28
|
Day 28
|
|
Circulating endothelial cells cytokines profile
大体时间：Day 1 and 3
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Dosage of cytokines from circulating endothelial cells
|
Day 1 and 3
|
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Circulating endothelial cells chemokines profile
大体时间：Day 1 and 3
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Dosage of chemokines from circulating endothelial cells
|
Day 1 and 3
|
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Expression of membrane proteins of endothelial cells
大体时间：Day 1 and 3
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Expression of membrane proteins of endothelial cells by flow cytometry
|
Day 1 and 3
|
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Infection site
大体时间：Day 1
|
Infection site for patients with sepsis
|
Day 1
|
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Infection identification
大体时间：Day 1
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Identified germs for patients with sepsis
|
Day 1
|
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Number of participants with different types of antibiotic treatment
大体时间：Length of ICU stay, assessed up to 90 days
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Antibiotic treatments for patients with sepsis during intensive care unit (ICU) stay
|
Length of ICU stay, assessed up to 90 days
|
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 (预期的)
2021年4月1日
初级完成 (预期的)
2026年4月1日
研究完成 (预期的)
2026年8月1日
研究注册日期
首次提交
2021年4月2日
首先提交符合 QC 标准的
2021年4月8日
首次发布 (实际的)
2021年4月12日
研究记录更新
最后更新发布 (实际的)
2021年4月12日
上次提交的符合 QC 标准的更新
2021年4月8日
最后验证
2021年4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.