Analysis of the Pulmonary Microbiota in a Cohort of Critically Ill Patients Admitted to the Intensive Care Unit. Prospective, Observational Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Microbiota
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients
Time Frame: 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
Secondary Outcomes
- Mortality at 28 and 90 days(36 months)
- Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation(36 months)
- Microbiological eradication, defined by a sterile BAL(36 months)
- Duration of mechanical ventilation, in days(36 months)
- Duration of cathecolamins administration, in days(36 months)
- Hospital and ICU lenght of stay, in days(36 months)