ESICM UNITE COVID-19 Project (UNITE-COVID)

Study Overview
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Brief Summary
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COVID-19 is arguably the biggest challenge critical care medicine has been confronted with since its conception. Critical care services around the world are flooded by patients presenting with severe respiratory failure who require prolonged treatment in the ICU. Despite the support provided, outcomes are poor, particularly in ventilated patients. Many unanswered questions remain regarding the pathophysiology of COVID-19, particularly in severely ill patients. No evidence-based treatment is currently available, yet different often experimental therapies are administered to patients. As experience grows, new phenotypes are recognized, and unreported complications are observed in the most severely ill patients. Although many registries are currently including patients, few of them focus on ICU patients and their specific treatments and newly observed complications and challenges. Although the pandemic may appear on its return in many countries that are now easing the restrictions that were put in place to limit the spread of the disease, it can be expected that COVID-19 will be a continued challenge in ICUs globally until a safe and effective vaccine is found. Efforts to study the disease should continue in order to advance our understanding of the disease as well as improve treatment options.

Detailed Description
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This is a multicenter, international, anonymized point prevalence study. Patients who were present in the ICU on the day in April 2020 with the highest number of COVID-19 patients in the unit. Data can be entered in the database until July 2020. Retrospective data collection and entry is allowed. Subjects believed to fulfill all eligibility criteria, and none of the exclusion criteria, detailed in the relevant section of this protocol, will be included in the study. Data will be entered in the database anonymously. Data will consist of two core elements: Center data (to be completed once) Patient data For different domains with specific, highly relevant and un(der)explored ICU research questions, an focused data set is to be completed. These domains include: Respiratory Coagulation and thrombo-embolic events Infectious complications Rehabilitation Renal

Official Title
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European Society Of Intensive Care Medicine COVID-19 Project (UNITE-COVID)

Conditions
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COVID-19 Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is present in an ICU or in any other place of the hospital under the care of the critical care team on the day between 15th February 2020 and 15th June 2020 with the highest number of COVID-19 patients in the unit. The exact date can be decided by the local investigator. COVID-19 confirmed diagnosis through PCR or equivalent diagnostic technique Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from the study: SARS-CoV2 positive without COVID-19

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients admitted with confirmed COVID19 infection | Number of patients in the ICU on the study day | One day with 60 day follow-up | 
| Mortality (ICU) | Proportion of patients who have died at ICU discharge | One day with 60 day follow-up | 
| Mortality (60-day) | Proportion of patients who have died at day 60 | One day with 60 day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization in the ICU | Length of stay in the ICU | One day with 60 day follow-up | 
| Proportion of patients requiring invasive mechanical ventilation | Proportion of patients who require invasive mechanical ventilation during ICU stay versus all patients | One day with 60 day follow-up | 
| Proportion of patients developing infections during ICU stay | Proportion of patients who acquire an infection during their ICU stay versus all patients | One day with 60 day follow-up | 
| Proportion of patients developing thromboembolic events during ICU stay | Proportion of patients who develop any thromboembolic event during their ICU stay versus all patients | One day with 60 day follow-up | 
| Proportion of patients requiring tracheotomy during ICU stay | Proportion of patients who are require a tracheostomy versus all patients | One day with 60 day follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Infection, Inflammation, respiratory distress, coagulation, thromboembolus, rehabilitation, renal, cardiac, mobilization