Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut de Recerca Biomèdica de Lleida
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 population
Critical patients admited to the intensive care unit of the 3 participant hospitals whot meet the eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
246 Participants
are grouped into 2 trial groupsGroup A: post-ICU with ARDS
Group B: post-ICU without ARDS
Trial outcomes
Primary outcomes
1
Changes in lung diffusing capacity
Changes in the results of lung diffusing capacity (DLCO) in terms of mL/mmHg/MI
Time frame
3, 6 and 12 months2
Changes in lung diffusing capacity
Changes in the results of lung diffusing capacity (DLCO) in terms of percentage (%)
Time frame
3, 6 and 12 months3
Changes in lung volumes
Changes in the results of lung capacity or total lung capacity (TLC) in terms of Liters (L)
Time frame
3, 6 and 12 months4
Changes in lung volumes
Changes in the results of lung capacity or total lung capacity (TLC) in terms of percentage (%)
Time frame
3, 6 and 12 monthsSecondary outcomes
1
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.
Time frame
3, 6 and 12 months2
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.
Time frame
3, 6 and 12 months3
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.
Time frame
3, 6 and 12 months4
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.
Time frame
3, 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut de Recerca Biomèdica de Lleida
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Source ClinicalTrials.gov