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.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Angers、フランス、49000
- CHU Angers
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Le Mans、フランス、72000
- Centre Hospitalier du Mans
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Rennes、フランス、35000
- Chu Rennes
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall hospital mortality among included patients
時間枠: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
時間枠: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.
時間枠: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
時間枠: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
時間枠: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
時間枠: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.
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CHM-2021/S03/10
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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