此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19

2022年2月26日 更新者:Michelle Chew、Linkoeping University

Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19 During the First 60 Days of the 2020 Pandemic

This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic.

The main goal is to describe demographic characteristics, coexisting conditions, treatments and outcomes among critically ill patients with COVID-19. A secondary goal is to identify independent risk factors associated with increased mortality for these patients.

Data regarding baseline characteristics including comorbidities, intensive care treatments and outcomes will be extracted. ICU lengths of stay and 30-day mortalities will be calculated. The primary outcome is 30-day all-cause mortality. THIS PART OF THE STUDY HAS BEEN COMPLETED.

UPDATE 26 Feb 2022:

Characteristics and outcomes of 'first wave' patients admitted to Swedish ICUs was published in Eur J Anaesthesiol. 2021 Apr 1;38(4):335-343. doi: 10.1097/EJA.0000000000001459.

A description of the surge response and aggregated data outcomes in Scandinavian countries was published in https://onlinelibrary.wiley.com/doi/10.1111/aas.13983.

ADDITIONAL SUMMARY - EXTENDED INCLUSION PERIOD AND ADDITION OF LONG-TERM OUTCOMES Due to the continued influx of patients requiring intensive care throughout 2020 and 2021, we extended the inclusion period to 30 June 2021. Thus this new cohort will include all patients admitted to ICUs in Sweden from 6 March 2020 to 30 June 2021.

We will investigate short (30day mortality) and long-term outcomes (365d mortality and cardiovascular complications) of patients admitted to Swedish ICUs with confirmed SARS-CoV-2 infection and COVID-19 disease.

研究概览

地位

主动,不招人

详细说明

Previous studies reporting outcomes for COVID-19 patients admitted to intensive care units (ICUs) have been hampered by right-censoring after short observation periods. None have reported 30-day mortality rates and the vast majority of studies have substantial proportions of undischarged patients at the time of follow-up. The lack of follow-up at least to ICU discharge may cause bias in reported mortality rates. Further, national data on critically ill patients have not been previously published.

UPDATE 26 Feb 2022: A number of large, cohort studies including national population outcomes have now been published.

This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic. The Swedish Intensive Care Registry (SIR) collects data on patients admitted to all Swedish ICUs, with 100% coverage since 2019. Thus, SIR is able to report on outcomes in a national intensive care population without selection. Little is known about the epidemiology of COVID-19 infections in Sweden, which has one of the world's highest life expectancies and a significant burden of comorbidity. Coupled with Sweden's 'relaxed' approach to COVID-19 pandemic management, health care outcomes are understandably under question.

The main goal is to describe demographic characteristics, coexisting conditions, treatments and outcomes among critically ill patients with COVID-19. A secondary goal is to identify independent risk factors associated with increased mortality for these patients.

ADDITIONAL SUMMARY updated 20 October 2021 Due to the continued influx of COVID-19 patients in ICUs in Sweden throughout 2020 and 2021, we extended of our sample size to encompass all patients admitted up to 30 June 2021 (previously 6 May 2020).

We aim to investigate short- and long-term outcomes including mortality and the incidence of new cardiovascular and respiratory diagnoses up to one year after inclusion.

On 22 mar 2021 we received ethical committee approval for these extensions.

研究类型

观察性的

注册 (预期的)

7500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Östergötland
      • Linköping、Östergötland、瑞典、50185
        • Department of Anaesthesia and Intensive Care, Linkoeping University Hospital, Region Östergötland

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult patients (≥18 years)

admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic (6 March-6May2020).

描述

Inclusion Criteria:

  • Adult patients (≥18 years)
  • COVID-19 disease

Exclusion Criteria:

  • No Swedish personal identity number
  • 'Opt out' from Swedish Intensive Care Registry

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:追溯

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
30-day mortality
大体时间:30 days
all-cause
30 days
365-day mortality
大体时间:365 days (additional outcome added Oct 2021 after additional approval from ethical committee)
all-cause
365 days (additional outcome added Oct 2021 after additional approval from ethical committee)

次要结果测量

结果测量
措施说明
大体时间
ICU mortality
大体时间:30 days
all cause
30 days
Morbidity
大体时间:up to 365 days after study inclusion
Cardiovascular and Respiratory Diseases
up to 365 days after study inclusion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年3月6日

初级完成 (实际的)

2020年5月6日

研究完成 (预期的)

2022年12月31日

研究注册日期

首次提交

2020年7月6日

首先提交符合 QC 标准的

2020年7月7日

首次发布 (实际的)

2020年7月8日

研究记录更新

最后更新发布 (实际的)

2022年3月14日

上次提交的符合 QC 标准的更新

2022年2月26日

最后验证

2022年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Unidentified data will be shared conditional upon application to the CI

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

新冠肺炎的临床试验

Admission to ICU for COVID-19的临床试验

3
订阅