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临床试验/NCT04743232
NCT04743232暂停不适用

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) or COVID-19 Pandemic Resuscitation Plans and Decisions on Escalation and Limitation of Treatment

Erasmus Medical Center7 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
200
试验地点
7
主要终点
ICU-admissions

研究概览

简要总结

During the Corona Virus Pandemic health care resources have become scare, and the pandemic has brought forth the need for risk stratification of patients suffering from COVID19 in order to allocate resources appropriately. One of scarcest resources is Intensive Care treatment, mostly related to the need for invasive ventilation or for (post) cardiac arrest care.

To identify patients for whom ICU-treatment is most successful and those for whom it would be futile, would allow for installing appropriate advanced care directives for escalation or limitation of treatment.

详细描述

Disease resulting from infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has a high mortality rate with deaths predominantly caused by respiratory failure. As of 1 September 2020, over 25 million people had confirmed coronavirus disease 2019 (COVID-19) worldwide and at least 850 000 people had died from the disease. As hospitals around the world are faced with an influx of patients with COVID-19, there is an urgent need for a pragmatic risk stratification tool that will allow the early identification of patients infected with SARS-CoV-2 who are at the highest risk of death to guide management and optimise resource allocation.

As is apparent not only from medical literature, but also from popular media, there is a need for risk stratification and decision aid. The problem with our current health care capacity mainly pertains to ICU-admissions. Ideally, clinicians would be able to predict who benefits from invasive ICU-treatment, and who does not. Subsequently, patients for whom ICU-admission is futile,doctors can install advanced care directives to refrain from escalation and limit the curative treatment they receive, and rather focus on palliation. As the investigators of this study previously discovered, patients are not unwilling to discuss these matters. In COVID-19 patients, three interventions seem logical to warrant special attention: ICU-admission, invasive ventilatory support and cardiopulmonary resuscitation. The latter because mortality in cardiac arrest patients with concurrent COVID appears higher than in non-COVID patients and performing CPR in patients with contagious diseases can potentially bring harm to health care providers.

Prognostic scores attempt to transform complex clinical pictures into tangible numerical values.

Dutch clinicians in general have been particularly busy identifying and providing prognostic scores for mortality and ICU-admission. Recent reviews listed many prognostic scores used for COVID-19, which varied in their setting, predicted outcome measure, and the clinical parameters included. It also highlights the importance of age, something that has been a subject to political debate. Therefore, in the past months, two Dutch research groups and one British group have developed two prognostic scores:

  1. COVID Outcome Prediction in the Emergency department:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • •adults with COVID19 (proven by polymerase chain reaction, or with strong clinical suspicion based on clinical features and/or radiodiagnostics)

排除标准

  • 未提供

研究组 & 干预措施

Standard practice

No Intervention

Standard practice concerning advanced care directives; care as usual

Decision aid implementation

Experimental

Stepped-wedge implementation of the intervention

干预措施: Decision tool for clinicians (Other)

结局指标

主要结局

ICU-admissions

时间窗: before and after the intervention; total duration is 12 weeks.

number of ICU-admissions at baseline and after implementation of the intervention

次要结局

  • Mortality(before and after the intervention; patient follow-up at 30 days and 1 year)
  • Health care professionals' satisfaction(Measurements are repeated, before and after the intervention; total duration is 12 weeks.)
  • Patient satisfaction(Measurement is only done once. In one group of patients before and another group after the intervention; total duration is 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Schluep

Anesthesiologist-intensivist

Erasmus Medical Center

研究点 (7)

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