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

NCT06083363 | Recruiting

• 1 other identifier: PI23/01381
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

ARDS; ARDS Disease Progression

Keywords

ARDS; ICU

Outcome Measures

Primary Outcomes (5)

• Changes in lung diffusing capacity

  Changes in the results of lung diffusing capacity (DLCO) in terms of mL/mmHg/MI

  3, 6 and 12 months

• Changes in lung diffusing capacity

  Changes in the results of lung diffusing capacity (DLCO) in terms of percentage (%)

  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)

  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 (%)

  3, 6 and 12 months

• Changes in chest CT findings

  Identification of structural pulmonary sequelae in terms of chest CT findings

  3, 6 and 12 months

Secondary Outcomes (14)

• Changes in the perceived cognitive difficulties

  3, 6 and 12 months

• Changes in the cognitive function

  3, 6 and 12 months

• Changes in the fatigue status

  3, 6 and 12 months

• Changes in the levels of anxiety

  3, 6 and 12 months

• Changes in independence to carry out daily activities

  3, 6 and 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critical patients admited to the intensive care unit of the 3 participant hospitals whot meet the eligibility criteria.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (3)

Hospital de Tortosa Verge de la Cinta

Tortosa, Tarragona, 43500, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Hospital Universitari Joan XXIII

Tarragona, 43005, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Per visit: 2 EDTA Tubes (6ml) 1 Tempus RNS tube (2,5ml)

Study Officials

• Jessica González Gutiérrez, MD, PhD

  Institut de Recerca Biomèdica de Lleida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica González Gutiérrez, MD, PhD

CONTACT

973 70 53 72; jgonzalezgutierrez88@gmail.com

Ferran Barbé Illa, MD, PhD

CONTACT

973 70 53 72; febarbe.lleida.ics@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Doctor of Philosophy

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 16, 2023
• Study Start: June 29, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)