Pulmonary Inflammation in COVID-19 ARDS

NCT ID: NCT04935450

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-12
• Study Completion Date: 2021-08-16

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.

Conditions

ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2; COVID-19 Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Bronchoalveolar lavage

Low volume Broncho alveolar lavage. During optic flexible bronchoscopy through the tracheal tube or the tracheostomy cannula a maximum of 4 aliquots of 20 ml normal saline will be instilled in a wedged position in the right medium lobe of the patients and then aspirated untill reaching a total of 25ml of fluid (BALF) for analysis

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Tommaso Bardi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

TOMMASO BARDI, MD

Role: CONTACT

tommaso.bardi@gmail.com

+34640350484

Facility Contacts

TOMMASO BARDI, MD

Role: primary

tommaso.bardi@gmail.com

+34640350484

Other Identifiers

398-20

Identifier Type: -

Identifier Source: org_study_id