ARDSTENACITYNCT06083363
Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding
An observational study of ARDS and ARDS Disease Progression, run by Institut de Recerca Biomèdica de Lleida at 3 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, ARDS Disease Progression
- How many people
- 246 participants
- Where
- 3 sitesSpain
- Study dates
- 29 Jun 2023to 30 Jun 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical patients admited to the intensive care unit of the 3 participant hospitals whot meet the eligibility criteria.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari Arnau de Vilanova
Lleida, Lleida, 25198
Hospital Universitari Joan XXIII
Tarragona, Tarragona, 43005
Hospital de Tortosa Verge de la Cinta
Tortosa, Tarragona, 43500
About this study
Official title: Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding. The TENACITY Study
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.
Read the detailed description
The coronavirus disease 2019 (COVID-19) resulted in the largest cohort of critical illness survivors in history, heightened awareness of the importance of the multi-dimensional sequelae after an acute distress respiratory syndrome (ADRS). With the advancement of acute-phase ARDS management, it is unknown whether there are differences in longitudinal recovery trajectories in terms of lung function, symptoms, quality of life, neurocognitive disorders, exercise capacity, chest imaging, and even at molecular basis between patients with post-ARDS due to COVID-19 and due to other causes. This project will continue to generate information about non-COVID-19 post-ARDS based on the experience in our post-COVID consultation that began in May 2020.
The main objective of the study is to identify risk factors of pulmonary sequela in terms of DLCO at long-term follow-up in survivors of ARDS. The investigators are also interested in describing the long-term longitudinal recovery trajectories at a multidimensional level (symptoms, quality of life, neurocognitive, other lung function parameters, exercise capacity, chest imaging and molecular profiles) of ARDS survivors. Furthermore, risk factors as well as recovery trajectories will be compared between ARDS caused by COVID-19 and non-COVID-19. The ultimate goal is to understand the pathobiological mechanisms associated with a severe lung injury at the long term (one year after hospital discharge), in order to provide novel therapeutic targets to develop future intervention studies.
For doing so, adult ARDS survivors of any origin (different than COVID-19) (n=246) referred to the post-CRITICAL consultation at the University Hospitals of Arnau de Vilanova and Santa Maria (Lleida), University Hospital Joan XXIII (Tarragona) and Verge de la Cinta (Tortosa) will be included in this multicentric, prospective, longitudinal and observational study. Previous standardized protocol will be followed at 3, 6 and 12 months after hospital discharge with a complete evaluation of symptoms, neurocognitive, memory problems and quality of life. Lung function, exercise test, chest CT and molecular analysis will be performed at each time point. The prognostic factors and the longitudinal recovery trajectories of ARDS survivors will be assessed using latent class mixed and machine learning artificial models.
The specific objectives to achieve the general objective are the following:
- Objective 1: To identify risk factors of lung function sequelae (spirometry, total lung volumes and lung diffusing capacity) in non-COVID-19 ARDS survivors.
- Objective 2: To identify risk factors of structural pulmonary sequelae (chest CT findings) in non-COVID-19 ARDS survivors.
- Objective 3: To identify risk factors of symptoms, neurocognitive disorders (BC-CCI, MOCA) and quality of life (SF-12) in non-COVID-19 ARDS survivors.
- Objective 4: To develop a clinical scoring tool to predict pulmonary sequelae at short- and long-term follow-up.
- Objective 5: To compare risk factors and recovery trajectories with COVID-19 ARDS survivors using data previously collected.
- Objective 6: To use artificial intelligence to identify multidimensional phenotypes associated with recovery trajectories.
- Objective 7: To design a cost-effective follow-up plan after hospital discharge in ARDS patients based on hospital risk factors.
- Objective 8: To identify molecular profiles according to recovery trajectories in non-COVID-19 ARDS.
- Conditions
- ARDS, ARDS Disease Progression
- Keywords
- ARDS, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lung diffusing capacity
Changes in the results of lung diffusing capacity (DLCO) in terms of mL/mmHg/MI
Measured: 3, 6 and 12 months
Changes in lung diffusing capacity
Changes in the results of lung diffusing capacity (DLCO) in terms of percentage (%)
Measured: 3, 6 and 12 months
Changes in lung volumes
Changes in the results of lung capacity or total lung capacity (TLC) in terms of Liters (L)
Measured: 3, 6 and 12 months
Changes in lung volumes
Changes in the results of lung capacity or total lung capacity (TLC) in terms of percentage (%)
Measured: 3, 6 and 12 months
Changes in chest CT findings
Identification of structural pulmonary sequelae in terms of chest CT findings
Measured: 3, 6 and 12 months
Secondary outcomes (14)
Changes in the perceived cognitive difficulties
Changes in the results of the British Columbia Cognitive Complaints Inventory (BC-CCI) test.
The scale consists of 6 items assessing perceived problems with concentration, memory, expressing thoughts, word finding, slow thinking, and difficulty solving problems in the past 7 days. Scores on each item (ranging from 0, not at all, to 3, very much) are summed to yield a total score ranging from 0 to 18; higher scores indicate greater severity of cognitive complaints.
Measured: 3, 6 and 12 months
Changes in the cognitive function
Changes in the results of Montreal Cognitive Assessment (MoCA) test.
The MoCA test examines seven domains of cognitive function with a total of 11 different exercises and tasks. The total score ranges from 0 to 30, lower scores indicate greater severity of cognitive impairment.
Measured: 3, 6 and 12 months
Changes in the fatigue status
Changes in the results of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4)
This scale is a short test of 13-item that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is 0-52, being the higher the score, the better the quality of life and less perception of fatigue.
Measured: 3, 6 and 12 months
Changes in the levels of anxiety
Changes in the results of Hospital Anxiety and Depression Scale (HAD)
The scale determines the levels of anxiety and depression that a person is experiencing. It is a 14 item scale (7 of the items relate to anxiety and 7 relate to depression). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Lower scores indicate less anxiety or depression.
Measured: 3, 6 and 12 months
Changes in independence to carry out daily activities
Changes in the results of Barthel test.
Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence. This score is calculated by simply totaling the individual item scores.
Measured: 3, 6 and 12 months
Changes in the perception of life quality
Changes in the results of 12-Item Short Form Survey (SF-12) test.
The SF-12 is a self-reported outcome measure composed by 12 items which examine eight dimensions of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: 3, 6 and 12 months
Validation of a clinical scoring tool
Validation of a clinical scoring tool to predict pulmonary sequelae at short- and long-term follow-up.
Measured: 3, 6 and 12 months
Cost-effectiveness of a follow-up plan
Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained
Measured: 3, 6 and 12 months
Identification of molecular profiles
Classification of the population in different molecular profiles according to their recovery trajectories
Measured: 3, 6 and 12 months
Multidimensional phenotypes
multidimensional phenotypes associated with recovery trajectories defined with artificial intelligence
Measured: 3, 6 and 12 months
Recovery trajectories of lung diffusing capacity
Comparison of risk factors and recovery trajectories in terms of lung diffusing capacity (DLCO) with COVID-19 ARDS survivors using data previously collected.
Measured: 3, 6 and 12 months
Recovery trajectories of total lung capacity
Comparison of risk factors and recovery trajectories in terms of total lung capacity (TLC) with COVID-19 ARDS survivors using data previously collected.
Measured: 3, 6 and 12 months
Recovery trajectories of perception of life quality
Comparison of risk factors and recovery trajectories in terms of perception of life quality (SF12 test) with COVID-19 ARDS survivors using data previously collected.
Measured: 3, 6 and 12 months
Recovery trajectories of perception of fatigue
Comparison of risk factors and recovery trajectories in terms of perception of fatigue (FACIT-4 test) with COVID-19 ARDS survivors using data previously collected.
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start29 Jun 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Jessica González Gutiérrez MD, PhD, Institut de Recerca Biomèdica de Lleida
- Investigators
- Jessica González Gutiérrez, MD, PhD, Principal investigator, Institut de Recerca Biomèdica de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083363
- Sponsor's protocol ID
- PI23/01381
- Acronym
- TENACITY
- Status last verified
- Nov 2026
- First submitted
- 4 Sep 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding. The TENACITY Study
- ClinicalTrials.gov ID
- NCT06083363
- Acronym / sponsor ID
- TENACITY / PI23/01381
- Conditions
- ARDS, ARDS Disease Progression
- Keywords
- ARDS, ICU
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Institut de Recerca Biomèdica de LleidaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The coronavirus disease 2019 (COVID-19) resulted in the largest cohort of critical illness survivors in history, heightened awareness of the importance of the multi-dimensional sequelae after an acute distress respiratory syndrome (ADRS). With the advancement of acute-phase ARDS management, it is unknown whether there are differences in longitudinal recovery trajectories in terms of lung function, symptoms, quality of life, neurocognitive disorders, exercise capacity, chest imaging, and even at molecular basis between patients with post-ARDS due to COVID-19 and due to other causes. This project will continue to generate information about non-COVID-19 post-ARDS based on the experience in our post-COVID consultation that began in May 2020.
The main objective of the study is to identify risk factors of pulmonary sequela in terms of DLCO at long-term follow-up in survivors of ARDS. The investigators are also interested in describing the long-term longitudinal recovery trajectories at a multidimensional level (symptoms, quality of life, neurocognitive, other lung function parameters, exercise capacity, chest imaging and molecular profiles) of ARDS survivors. Furthermore, risk factors as well as recovery trajectories will be compared between ARDS caused by COVID-19 and non-COVID-19. The ultimate goal is to understand the pathobiological mechanisms associated with a severe lung injury at the long term (one year after hospital discharge), in order to provide novel therapeutic targets to develop future intervention studies.
For doing so, adult ARDS survivors of any origin (different than COVID-19) (n=246) referred to the post-CRITICAL consultation at the University Hospitals of Arnau de Vilanova and Santa Maria (Lleida), University Hospital Joan XXIII (Tarragona) and Verge de la Cinta (Tortosa) will be included in this multicentric, prospective, longitudinal and observational study. Previous standardized protocol will be followed at 3, 6 and 12 months after hospital discharge with a complete evaluation of symptoms, neurocognitive, memory problems and quality of life. Lung function, exercise test, chest CT and molecular analysis will be performed at each time point. The prognostic factors and the longitudinal recovery trajectories of ARDS survivors will be assessed using latent class mixed and machine learning artificial models.
The specific objectives to achieve the general objective are the following:
- Objective 1: To identify risk factors of lung function sequelae (spirometry, total lung volumes and lung diffusing capacity) in non-COVID-19 ARDS survivors.
- Objective 2: To identify risk factors of structural pulmonary sequelae (chest CT findings) in non-COVID-19 ARDS survivors.
- Objective 3: To identify risk factors of symptoms, neurocognitive disorders (BC-CCI, MOCA) and quality of life (SF-12) in non-COVID-19 ARDS survivors.
- Objective 4: To develop a clinical scoring tool to predict pulmonary sequelae at short- and long-term follow-up.
- Objective 5: To compare risk factors and recovery trajectories with COVID-19 ARDS survivors using data previously collected.
- Objective 6: To use artificial intelligence to identify multidimensional phenotypes associated with recovery trajectories.
- Objective 7: To design a cost-effective follow-up plan after hospital discharge in ARDS patients based on hospital risk factors.
- Objective 8: To identify molecular profiles according to recovery trajectories in non-COVID-19 ARDS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical patients admited to the intensive care unit of the 3 participant hospitals whot meet the eligibility criteria.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in lung diffusing capacity
Time frame: 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
Time frame: 3, 6 and 12 months
Changes in the results of lung diffusing capacity (DLCO) in terms of percentage (%)
Changes in lung volumes
Time frame: 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
Time frame: 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
Time frame: 3, 6 and 12 months
Identification of structural pulmonary sequelae in terms of chest CT findings
14 secondary outcomes
Changes in the perceived cognitive difficulties
Time frame: 3, 6 and 12 months
Changes in the cognitive function
Time frame: 3, 6 and 12 months
Changes in the fatigue status
Time frame: 3, 6 and 12 months
Changes in the levels of anxiety
Time frame: 3, 6 and 12 months
Changes in independence to carry out daily activities
Time frame: 3, 6 and 12 months
Changes in the perception of life quality
Time frame: 3, 6 and 12 months
Validation of a clinical scoring tool
Time frame: 3, 6 and 12 months
Cost-effectiveness of a follow-up plan
Time frame: 3, 6 and 12 months
Identification of molecular profiles
Time frame: 3, 6 and 12 months
Multidimensional phenotypes
Time frame: 3, 6 and 12 months
Recovery trajectories of lung diffusing capacity
Time frame: 3, 6 and 12 months
Recovery trajectories of total lung capacity
Time frame: 3, 6 and 12 months
Recovery trajectories of perception of life quality
Time frame: 3, 6 and 12 months
Recovery trajectories of perception of fatigue
Time frame: 3, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica González Gutiérrez, MD, PhD principal investigator
Institut de Recerca Biomèdica de Lleida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and ARDS Disease Progression, run by Institut de Recerca Biomèdica de Lleida at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lung diffusing capacity (time frame: 3, 6 and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.