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Trajetórias de recuperação longitudinal após uma síndrome de desconforto respiratório agudo, uma nova compreensão (TENACITY)

2 de novembro de 2026 atualizado por: Jessica González Gutiérrez MD, PhD, Institut de Recerca Biomèdica de Lleida

Trajetórias de recuperação longitudinal após uma síndrome de desconforto respiratório agudo, uma nova compreensão. O Estudo TENACIDADE

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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

246

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Espanha
- Lleida
  - Lleida, Lleida, Espanha, 25198
    - Hospital Universitari Arnau de Vilanova
- Tarragona
  - Tarragona, Tarragona, Espanha, 43005
    - Hospital Universitari Joan XXIII
  - Tortosa, Tarragona, Espanha, 43500
    - Hospital de Tortosa Verge de la Cinta

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: COHORT
Perspectivas de Tempo: PROSPECTIVE

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Changes in lung diffusing capacity Prazo: 3, 6 and 12 months	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 Prazo: 3, 6 and 12 months	Changes in the results of lung diffusing capacity (DLCO) in terms of percentage (%)	3, 6 and 12 months
Changes in lung volumes Prazo: 3, 6 and 12 months	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 Prazo: 3, 6 and 12 months	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 Prazo: 3, 6 and 12 months	Identification of structural pulmonary sequelae in terms of chest CT findings	3, 6 and 12 months

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Changes in the perceived cognitive difficulties Prazo: 3, 6 and 12 months	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.	3, 6 and 12 months
Changes in the cognitive function Prazo: 3, 6 and 12 months	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.	3, 6 and 12 months
Changes in the fatigue status Prazo: 3, 6 and 12 months	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.	3, 6 and 12 months
Changes in the levels of anxiety Prazo: 3, 6 and 12 months	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.	3, 6 and 12 months
Changes in independence to carry out daily activities Prazo: 3, 6 and 12 months	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.	3, 6 and 12 months
Changes in the perception of life quality Prazo: 3, 6 and 12 months	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.	3, 6 and 12 months
Validation of a clinical scoring tool Prazo: 3, 6 and 12 months	Validation of a clinical scoring tool to predict pulmonary sequelae at short- and long-term follow-up.	3, 6 and 12 months
Cost-effectiveness of a follow-up plan Prazo: 3, 6 and 12 months	Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained	3, 6 and 12 months
Identification of molecular profiles Prazo: 3, 6 and 12 months	Classification of the population in different molecular profiles according to their recovery trajectories	3, 6 and 12 months
Multidimensional phenotypes Prazo: 3, 6 and 12 months	multidimensional phenotypes associated with recovery trajectories defined with artificial intelligence	3, 6 and 12 months
Recovery trajectories of lung diffusing capacity Prazo: 3, 6 and 12 months	Comparison of risk factors and recovery trajectories in terms of lung diffusing capacity (DLCO) with COVID-19 ARDS survivors using data previously collected.	3, 6 and 12 months
Recovery trajectories of total lung capacity Prazo: 3, 6 and 12 months	Comparison of risk factors and recovery trajectories in terms of total lung capacity (TLC) with COVID-19 ARDS survivors using data previously collected.	3, 6 and 12 months
Recovery trajectories of perception of life quality Prazo: 3, 6 and 12 months	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.	3, 6 and 12 months
Recovery trajectories of perception of fatigue Prazo: 3, 6 and 12 months	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.	3, 6 and 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Institut de Recerca Biomèdica de Lleida

Colaboradores

Instituto de Salud Carlos III

Investigadores

Investigador principal: Jessica González Gutiérrez, MD, PhD, Institut de Recerca Biomèdica de Lleida

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de junho de 2023

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

30 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

4 de setembro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de outubro de 2023

Primeira postagem (Real)

16 de outubro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

PI23/01381

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .