ARDS, COVID-19
Conditions
Brief summary
The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS). This is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.
Interventions
OTHERCOVID-19
SARS-CoV-2 infection
OTHERARDS
Acute respiratory distress syndrome
Sponsors
Hospital Moinhos de Vento
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
COHORT OF SURVIVORS OF ARDS CAUSED BY COVID-19 Inclusion Criteria: * Age ≥18 years; * Hospitalization due to COVID-19; * Positive polymerase chain reaction (PCR) test for SARS-CoV-2; * Diagnosis of ARDS during hospitalization according to the Berlin definition; * Expected to survive and be discharged directly home from the hospital.
Exclusion criteria
* Severe comorbidity with life expectancy less than 3 months; * Unavailability to attend the study follow-up appointment; * Death during hospitalization; * Absence of proxy for patients with communication difficulties; * Refusal or withdrawal of agreement to participate. COHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19 Inclusion Criteria: * Age ≥18 years; * Hospitalization; * Diagnosis of ARDS during hospitalization according to the Berlin definition; * Expected to survive and be discharged directly home from the hospital.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diffusion capacity for carbon monoxide | The outcome will be assessed 6 months after enrollment | Proportion of participants with diffusion capacity for carbon monoxide \< 80% of predicted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Instrumental Activities of Daily Living | The outcome will be assessed at 3 and 6 months after enrollment | The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence) |
| Muscular function and strength | The outcome will be assessed at 3 and 6 months after enrollment | Muscular function and strength as assessed by Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire. Scale scores range from 0 (best) to 10 (worst) |
| Score of dyspnea | The outcome will be assessed at 3 and 6 months after enrollment | The outcome will be assessed using the modified medical research council dyspnea scale. Scores ranges from 0 to 4, with higher scores indicating worse symptoms. |
| Utility score of health related quality of life | The outcome will be assessed at 3 and 6 months after enrollment | The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health). |
| Radiologic patterns of intersticial lung disease | The outcome will be assessed at 6 months after enrollment | Radiologic patterns of intersticial lung disease as assessed by high resolution computed tomography chest scan. |
| Radiologic patterns of myocarditis sequalae | The outcome will be assessed at 6 months after enrollment | Radiologic patterns of myocarditis sequalae as assessed by cardiac magnetic resonance imaging |
| Radiologic patterns of sarcopenia | The outcome will be assessed at 6 months after enrollment | Radiologic patterns of sarcopenia as assessed by high resolution computed tomography chest scan. |
| Incidence of major cardiovascular events | The outcome will be assessed at 3 and 6 months after enrollment | Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death) |
| Incidence of thromboembolic events | The outcome will be assessed at 3 and 6 months after enrollment | Incidence of thromboembolic events (composite endpoint of pulmonary embolism and deep venous thrombosis) |
| Physical functional status | The outcome will be assessed at 3 and 6 months after enrollment | Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence) |
| Percentage of predicted peak oxygen consumption | The outcome will be assessed at 6 months after enrollment | Percentage of predicted peak oxygen consumption as assessed by treadmill cardiopulmonary exercise cardiopulmonary exercise |
| Peak oxygen consumption | The outcome will be assessed at 6 months after enrollment | Peak oxygen as assessed by treadmill cardiopulmonary exercise |
| Peak oxygen pulse | The outcome will be assessed at 6 months after enrollment | Peak oxygen pulse as assessed by treadmill cardiopulmonary exercise |
| Oxygen uptake efficiency slope | The outcome will be assessed at 6 months after enrollment | Oxygen uptake efficiency slope as assessed by treadmill cardiopulmonary exercise |
| Minute ventilation/carbon dioxide production slope ratio | The outcome will be assessed at 6 months after enrollment | Minute ventilation/carbon dioxide production slope as assessed by treadmill cardiopulmonary exercise |
| Forced vital capacity | The outcome will be assessed at 6 months after enrollment | Forced expiratory capacity as assessed by spirometry |
| Forced expiratory volume in one second | The outcome will be assessed at 6 months after enrollment | Forced expiratory volume in one second as assessed by spirometry |
| Forced expiratory volume in one second/ Forced vital capacity ratio | The outcome will be assessed at 6 months after enrollment | Forced expiratory volume in one second/ Forced vital capacity ratio as assessed by spirometry |
| Incidence of all-cause mortality | The outcome will be assessed at 3 and 6 months after enrollment | Incidence of all-cause mortality |
Contacts
Primary ContactGeraldine Trott, PhD
Outcome results
None listed