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临床试验/NCT05184166
NCT05184166已完成不适用

Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19

Centre Hospitalier le Mans4 个研究点 分布在 1 个国家目标入组 361 人开始时间: 2022年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
361
试验地点
4
主要终点
Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection

时间窗: 6 months

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

Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection

时间窗: 1 year after diagnosis of SarS-CoV-2

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

次要结局

  • Overall hospital mortality among included patients(during hospitalization)
  • In-hospital mortality among patients admitted to and not admitted to intensive care(end of hospitalization)
  • 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.(1 year after diagnosis of SarS-CoV-2)
  • Outcome for patients admitted and discharged alive from hospital in terms of Quality of life(1 year after diagnosis of SarS-CoV-2)
  • Outcome for patients admitted and discharged alive from hospital in terms of functionnal status(1 year after diagnosis of SarS-CoV-2)
  • Hospital care for patients not admitted to intensive care(during hospitalization)
  • 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.(1 year after diagnosis SARS-CoV-2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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