跳至主要内容
临床试验/NCT04462393
NCT04462393进行中(未招募)不适用

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

Linkoeping University1 个研究点 分布在 1 个国家目标入组 7,500 人开始时间: 2020年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
7,500
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

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.

UPDATE 13 Nov 2024:

ADDITIONAL SUMMARY - EXTENDED INCLUSION PERIOD AND ADDITION OF LONG-TERM OUTCOMES, AND CRITICALLY ILL PATIENTS WITH INFLUENZA AND VIRAL PNEUMONITIS Due to the continued influx of patients requiring intensive care due to COVID-19, we extended the inclusion period to 31 Dec 2022. Thus this new cohort will include all patients admitted to ICUs in Sweden from 6 March 2020 to 31 Dec 2022.

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.

In international research, the long-term effects of ICU-requiring COVID-19 are now highly topical. Long-term follow-up exceeding one year has not yet been conducted on any Swedish material. To concretely understand the actual implications of long-term outcomes, it is becoming almost standard to compare this patient group to ICU-requiring influenza + viral pneumonitis patients to some extent. We have applied for and obtained ethical approval to include this group as a potential comparator to COVID-19 patients.

However, such comparisons require careful consideration of potential confounders, such as patient characteristics and socioeconomic factors.

It is therefore crucial to both establish the disease burden for the population and relate it to a comparable patient group. Ethical approval and national data linkage approvals have now been obtained to extract this data from Statistics Sweden and the Swedish National Board of Health and Welfare registries. Data linkage was completed in October 2024.

详细描述

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).

研究设计

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

入排标准

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

入选标准

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

排除标准

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

结局指标

主要结局

30-day mortality

时间窗: 30 days

all-cause

365-day mortality

时间窗: 365 days (additional outcome added Oct 2021 after additional approval from ethical committee)

all-cause

次要结局

  • Morbidity(up to 365 days after study inclusion)
  • ICU mortality(30 days)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Michelle Chew

Professor

Linkoeping University

研究点 (1)

Loading locations...

相似试验