Clinical Trial

Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding

Study acronym: TENACITY
Recruiting
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Record status
This record was last updated March 6, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-10-11.
Status change: Not Yet Recruiting → Recruiting 2024-03-05
Trial Details
NCT Number NCT06083363
Lead Sponsor Institut de Recerca Biomèdica de Lleida
Collaborators: Instituto de Salud Carlos III
Conditions ARDS, ARDS Disease Progression
Enrollment 246 participants
Start Date 2023-06-29
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-03-06