Understanding recovery after acute respiratory distress syndrome
Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding. The TENACITY Study
This study looks at how well people recover after surviving acute respiratory distress syndrome, especially those affected by COVID-19, to see how their lung function, symptoms, and overall quality of life change over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 246 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de Recerca Biomèdica de Lleida Academic / other |
| Locations | 3 sites (Tortosa, Tarragona and 2 other locations) |
| Trial ID | NCT06083363 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the long-term recovery trajectories of patients who have survived acute respiratory distress syndrome (ARDS), particularly focusing on those affected by COVID-19 compared to other causes. It will assess various dimensions of recovery, including lung function, symptoms, quality of life, neurocognitive status, exercise capacity, and molecular profiles. The study seeks to identify risk factors for pulmonary sequelae and understand the underlying mechanisms of severe lung injury over a one-year follow-up period after hospital discharge.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been admitted to the ICU with a diagnosis of severe pneumonia or ARDS.
Not a fit: Patients with a life expectancy of less than a year or those unable to participate in pulmonary function tests due to severe mental disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of long-term respiratory complications in ARDS survivors.
How similar studies have performed: While there have been studies on ARDS recovery, this specific comparison between COVID-19 and non-COVID-19 ARDS recovery trajectories is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tortosa, Tarragona and 2 other locations
- Hospital de Tortosa Verge de la Cinta — Tortosa, Tarragona, Spain (Recruiting)
- Hospital Universitari Arnau de Vilanova — Lleida, Spain (Recruiting)
- Hospital Universitari Joan XXIII — Tarragona, Spain (Recruiting)
Study contacts
- Principal investigator: Jessica González Gutiérrez, MD, PhD — Institut de Recerca Biomèdica de Lleida
- Study coordinator: Jessica González Gutiérrez, MD, PhD
- Email: jgonzalezgutierrez88@gmail.com
- Phone: 973 70 53 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.