- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05184166
Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19 (ELDERCOV)
SARS-COV-2 infection can progress to acute respiratory distress syndrome and require hospitalization in the ICU in 5-20% of affected patients. Age is a major risk factor for developing a severe form and for death. ARDS related to SARS-COV-2 has specific features, including the need for long mechanical ventilation and length of stay and the use of corticosteroid therapy. These specificities are responsible for significant morbidity (neuromyopathy, delirium, post-resuscitation syndrome) and mortality during the first wave (46% at 3 months for the population of patients aged 70 years and over). To investigator's knowledge, no study has evaluated the prognosis in the ICU and the long-term functional outcome of elderly people admitted for a severe or critical form of COVID-19 since the major changes in management (dexamethasone, screening for thrombo-embolic complications, use of high-flow oxygen therapy as first-line treatment...).
Investigator therefore propose a 1-year follow-up of a cohort of patients aged 70 and over hospitalised in a conventional service or in intensive care for a severe or critical form of COVID-19. The objectives are to describe the prognosis and functional outcome of hospitalized elderly patients with severe COVID-19.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Angers, França, 49000
- CHU Angers
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Le Mans, França, 72000
- Centre Hospitalier du Mans
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Rennes, França, 35000
- CHU Rennes
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- age ≥ 70 years on admission to hospital
- diagnosis of SARS-CoV-2 infection defined by a positive RT-PCR test
- medical or critical care hospitalisation between 1 July 2020 and 31 August 2021
- who experienced severe hypoxaemic acute respiratory failure defined as at least 4L/min of oxygen during hospitalisation
Exclusion Criteria:
- Oxygen therapy < 4L/min during hospitalisation
- Mc Cabe score 3 (chronic disease fatal at 1 year such as stage IV heart failure, ventilated respiratory failure, metastatic cancer, Child C cirrhosis)
- dementia or cognitive disorders before hospitalisation reported in the medical record
- patient GIR 1 to 4 before hospitalisation reported in the medical file or deduced from the description of the lifestyle
- patient with an ADL score < 4 before hospitalisation reported in the medical record or deduced from the description of lifestyle
- patient living in EHPAD before hospitalisation
- non-French speaking patient
- patient under guardianship or curatorship
- refusal to participate in the study for patients surviving 1 year or refusal by a family member or trusted person
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection
Prazo: 1 year after diagnosis of SarS-CoV-2
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The mortality was evaluated by the proportion of patients aged 70 years and over who died 1 year after diagnosis of SARS-CoV-2 infection who had severe acute respiratory failure defined by at least 4 L/min of oxygen therapy
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1 year after diagnosis of SarS-CoV-2
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall hospital mortality among included patients
Prazo: during hospitalization
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Mortality was evaluated by proportion of patients included who died during their stay at the participating center
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during hospitalization
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In-hospital mortality among patients admitted to and not admitted to intensive care
Prazo: end of hospitalization
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Mortality was ecaluated by proportion of patients not admitted to intensive care who died during their stay in the participating center and proportion of patients admitted to intensive care who died in intensive care and during their stay in the participating center
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end of hospitalization
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Mortality 1 year after diagnosis of SARS-CoV-2 infection in patients who were discharged alive from hospital in the overall cohort and according to whether or not they were admitted to intensive care.
Prazo: 1 year after diagnosis of SarS-CoV-2
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Mortality was evaluated by Proportion of patients who died 1 year after diagnosis of SARS-CoV-2 infection among subjects included and discharged alive from the participating center, in the overall cohort and then according to whether or not they were admitted to intensive care.
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1 year after diagnosis of SarS-CoV-2
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Outcome for patients admitted and discharged alive from hospital in terms of Quality of life
Prazo: 1 year after diagnosis of SarS-CoV-2
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Quality of life was evaluated by Medical Outcome Study Short Form 36 (SF 36)
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1 year after diagnosis of SarS-CoV-2
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Outcome for patients admitted and discharged alive from hospital in terms of functionnal status
Prazo: 1 year after diagnosis of SarS-CoV-2
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Functionnal status was evaluated by Activities of Daily Living Scale (from 0 to 6), by Clinical Fragility Score - CFS (7 levels of frailty (from excellent health to severe frailty)) and proportion of patients institutionalized in residential care facilities for dependent elderly people (EHPAD) or in long-term care units (USLD)
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1 year after diagnosis of SarS-CoV-2
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Hospital care for patients not admitted to intensive care
Prazo: during hospitalization
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Proportion of patients admitted to intensive care and not admitted to intensive care
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during hospitalization
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Risk factors associated with 1-year outcomes in patients surviving hospitalization in the overall cohort and in the cohort of patients admitted to intensive care.
Prazo: 1 year after diagnosis SARS-CoV-2
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The outcome for patients will be defined as good prognosis (patient alive with an ADL score ≥ 4) and poor prognosis (patient alive with an ADL score < 4 or deceased patient).
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1 year after diagnosis SARS-CoV-2
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CHM-2021/S03/10
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