Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding. The TENACITY Study

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

COVID-19 resulted in the largest cohort of critical illness survivors in history, heightened awareness of the importance of the respiratory sequelae after an acute distress respiratory syndrome (ADRS). Despite the advancement of acute-phase ARDS management, it is unknown whether there are differences in the longitudinal recovery trajectories between patients with post-ARDS due to COVID-19 and due to other causes. The main objective of the study is to identify risk factors of pulmonary sequela (lung diffusing capacity) at long-term follow-up in survivors of ARDS. The investigators are also interested in describing the long-term longitudinal recovery trajectories at a multi-dimensional level (symptoms, quality of life, neurocognitive, other lung function parameters, exercise capacity, chest imaging and molecular profiles) of ARDS survivors, and compared between ARDS caused by COVID-19. The ultimate goal is to understand the pathobiological mechanisms associated with a severe lung injury at the long term, allowing the introduction of clinical guidelines for the management of post-ARDS patients and the assignment of personalized interventions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male and female patients aged ≥18 years

• Admission to the ICU

• Diagnosis of severe pneumonia and/or diagnosis of acute respiratory distress syndrome (ARDS) based on the 2023 definition due to any origin (infectious and non-infectious)

Locations
Other Locations
Spain
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Hospital Universitari Joan XXIII
RECRUITING
Tarragona
Hospital de Tortosa Verge de la Cinta
RECRUITING
Tortosa
Contact Information
Primary
Jessica González Gutiérrez, MD, PhD
jgonzalezgutierrez88@gmail.com
973 70 53 72
Backup
Ferran Barbé Illa, MD, PhD
febarbe.lleida.ics@gencat.cat
973 70 53 72
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 246
Treatments
post-ICU with ARDS
Patients admitted to the ICU who have developed Acute Respiratory Distress Syndrome (ARDS), as defined according the new 2023 guidelines (Matthay et.al, 2023)
post-ICU without ARDS
Patients admitted to the ICU who have suffered a severe pneumonia, needing advanced respiratory support, but without developing ARDS according to the new 2023 guidelines.
Sponsors
Collaborators: Instituto de Salud Carlos III
Leads: Institut de Recerca Biomèdica de Lleida

This content was sourced from clinicaltrials.gov