NCT04935450

Pulmonary Inflammation in COVID-19 ARDS

Pulmonary Inflammation Profiles in COVID-19 Related ARDS

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2020-12-12
• Primary completion: 2021-08-15
• Completion: 2021-08-16
• First posted: 2021-06-23
• Last updated: 2021-06-23

Locations

1 site across 1 country: Spain