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

NCT06083363 · tracked via the Priya Life Science Spain tracker

Sponsor

Institut de Recerca Biomèdica de Lleida

Phase

Observational

Started

2023-06-29

Last updated

2024-03-06

Condition(s) studied

ARDSARDS Disease Progression

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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) Exclusion Criteria: * Life expectancy less than a year * Transfer to another hospital during hospitalization or follow-up * Stay in palliative care * Severe mental disability that makes it impossible to carry out pulmonary function tests during follow-up

Primary outcome measure(s)

Changes in lung diffusing capacity — 3, 6 and 12 months
Changes in the results of lung diffusing capacity (DLCO) in terms of mL/mmHg/MI
Changes in lung diffusing capacity — 3, 6 and 12 months
Changes in the results of lung diffusing capacity (DLCO) in terms of percentage (%)
Changes in lung volumes — 3, 6 and 12 months
Changes in the results of lung capacity or total lung capacity (TLC) in terms of Liters (L)
Changes in lung volumes — 3, 6 and 12 months
Changes in the results of lung capacity or total lung capacity (TLC) in terms of percentage (%)
Changes in chest CT findings — 3, 6 and 12 months
Identification of structural pulmonary sequelae in terms of chest CT findings

Trial sites (3)

Facility	City	Region	Status
Hospital de Tortosa Verge de la Cinta	Tortosa	Tarragona	Recruiting
Hospital Universitari Arnau de Vilanova	Lleida	Spain	Recruiting
Hospital Universitari Joan XXIII	Tarragona	Spain	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06083363 on ClinicalTrials.gov ↗ ← All trials in Spain