Lung Microbiota Analysis in Critically Ill Patients Admitted to the Intensive Care Unit.
2022年3月23日 更新者:Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Analysis of the Pulmonary Microbiota in a Cohort of Critically Ill Patients Admitted to the Intensive Care Unit. Prospective, Observational Trial.
Our study aims to evaluate the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables among critically ill patients admitted to the intensive care unit (ICU).
In patients undergoing invasive mechanical ventilation, an aliquot of bronchoalveolar lavage (BAL) fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques.
研究概览
地位
招聘中
详细说明
Traditionally, microbiological investigations and clinical trials have contributed to the definition of lower airways as a physiologically sterile district, whose microbiological balance is altered when a respiratory infectious process occur.
Actually, the introduction of molecular study methods aiming at the identification of pathogens through genomic sequencing questioned the pardigm of "one bug-one disease", according to which we usually tend to consider a bronchial or pulmonary infectious event as due to the pathogenic role of a single exogenous microorganism.
In such a contest, there are truly few data dealing with the characterization of respiratory microbiota in human BAL as well as with the major determinants of this phenomenon and the possible impact on clinical and microbiological outcomes.
Our study, although it's a pilot one, aims to evaluate these aspects in a larger cohort of critically ill patients, observing the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables.
In patients undergoing invasive mechanical ventilation, an aliquot of BAL fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques.
For each enrolled patient, we will register demographic, clinical and laboratory variables.
The benefits deriving from this study lay in the possibility of improving the understanding of characteristics of critical patient's pulmonary microbioma and its clinical impact.
Such an information meets the increasingly topical need to customize medical interventions, especially in the context of critically ill patients.
研究类型
观察性的
注册 (预期的)
150
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:Gennaro De Pascale, MD
- 电话号码:+39 06 30154386
- 邮箱:gennaro.depascalemd@gmail.com
研究联系人备份
- 姓名:Simone Carelli, MD
- 邮箱:simonecarelli.sc@gmail.com
学习地点
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Rome、意大利、00168
- 招聘中
- Fondazione Policlinico A. Gemelli IRCCS
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接触:
- Gennaro De Pascale, MD
- 邮箱:gennaro.depascalemd@gmail.com
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接触:
- Simone Carelli, MD
- 邮箱:simonecarelli.sc@gmail.com
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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
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
All patients admitted to the ICUs and undergoing invasive mechanical ventilation (through oro-tracheal tube or tracheotomy)
描述
Inclusion Criteria:
- execution of bronchoalveolar lavage sampling, either for clinical indications or in the context of surveillance programs
- acquisition of an informed consent
Exclusion Criteria:
- presence of significant coagulation abnormalities and/or severe respiratory failure
- clearly bloody BAL sample
- small quantity of BAL sample (<5 ml)
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
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 |
|---|---|---|
|
Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients
大体时间:36 months
|
This aim will be achieved through the use of next-generation sequencing technologies and validate computational techniques, allowing us to taxonomically classify as well as to compare the germs present in BAL samples of ICU patients
|
36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation
大体时间:36 months
|
Relate composition and biodiversity of pulmonary microbioma with the occurence and time of clinical cure
|
36 months
|
|
Microbiological eradication, defined by a sterile BAL
大体时间:36 months
|
Relate composition ad biodiversity of pulmonary microbioma with the occurrence and time of microbiological eradication
|
36 months
|
|
Duration of mechanical ventilation, in days
大体时间:36 months
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Relate composition ad biodiversity of pulmonary microbioma with the duration of mechanical ventilation
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36 months
|
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Duration of cathecolamins administration, in days
大体时间:36 months
|
Relate composition ad biodiversity of pulmonary microbioma with the duration of cathecolamins administration
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36 months
|
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Hospital and ICU lenght of stay, in days
大体时间:36 months
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Relate composition ad biodiversity of pulmonary microbioma with hospital and ICU lenght of stay
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36 months
|
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Mortality at 28 and 90 days
大体时间:36 months
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Relate composition ad biodiversity of pulmonary microbioma with mortality at 28 and 90 days
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36 months
|
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
- 首席研究员:Gennaro De Pascale, MD、Fondazione Policlinico A. Gemelli IRCCS
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 (实际的)
2019年11月15日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2023年4月30日
研究注册日期
首次提交
2019年2月19日
首先提交符合 QC 标准的
2020年2月13日
首次发布 (实际的)
2020年2月17日
研究记录更新
最后更新发布 (实际的)
2022年3月25日
上次提交的符合 QC 标准的更新
2022年3月23日
最后验证
2022年3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.