Clinical trial NCT04935450: Pulmonary Inflammation in COVID-19 ARDS
Official title: Pulmonary Inflammation Profiles in COVID-19 Related ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19 Acute Respiratory Distress Syndrome
Keywords: ARDS
COVID-19
Broncho Alveolar Lavage
Pulmonary Inflammation
Mechanical Ventilation
Respiratory Mechanics
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 ARDS ICU patients

Brief summary: Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study.

This is an observational cohort study. After informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a Broncho Alveolar Lavage Fluid (BALF) sample will be collected. If the patients remain invasively mechanically ventilated a second and third blood and BALF sample will be collected every 7-10 days.

Detailed description: The main objective of the core study is to measure a number of biochemical, cellular and inflammatory mediators in the BALF of C-ARDS patients and evaluate their correlation with the course of disease in terms of respiratory mechanics, complications and outcomes.

The mediators selected have been previously used in ARDS investigation to attempt prognostic and predictive enrichment.

Patients hospitalized in the ICU following C-ARDS and requiring invasive mechanical ventilation will be candidates for enrollment.

Patients enrolled in the study (Informed consent obtained from next of kin) will be subject to the realization of optic bronchoscopy within the first 72 h of mechanical ventilation to obtain BALF for analysis. A second and third bronchoscopy and sampling of BALF will be performed every 7-10 days if mechanical ventilation and the clinical conditions allow it. A sample of whole blood will be taken contemporary to each bronchoscopy in order to perform parallel measurements (lungs and peripheral blood). Patients will be followed up until hospital discharge.

BALF samples will be divided to perform different analysis in the immunology, cytology and microbiology labs.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* COVID-19 related ARDS
* Hospitalized in ICU
* Invasive mechanical ventilation

Exclusion Criteria:

* Immunocompromised for previous condition
* transplanted patients
* Known pulmonary bacterial co-infection at the time of admission to the ICU
* Contraindication to the realization of Bronchoscopy (Itracranial Hypertension, severe hypoxaemia with P/F \< 80, severe hemodynamic instability, severe arrhythmia, non correctable coagulopathy)

Primary outcomes:
measure: Mortality
timeFrame: Up to 3 months
Secondary outcomes:
measure: Respiratory mechanics
timeFrame: Day 0 (after study inclusion) and every day up to 3 months
measure: BALF PCR
timeFrame: Day 0 (performance of first BALF sample) Day 8, Day 16
measure: BALF characteristics
timeFrame: Day 0 (performance of first BALF sample) Day 8, Day 16
measure: BALF cytoquines
timeFrame: Day 0 (performance of first BALF sample) Day 8, Day 16
Other outcomes:
measure: Hospital Mortality
timeFrame: Up to 3 months
measure: Health related quality of life via SF-36 questionnaire
timeFrame: Up to 3 months
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
Study officials:
References: