ESICM UNITE COVID-19 Project (UNITE-COVID) (UNITE-COVID)
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|ClinicalTrials.gov Identifier: NCT04836065|
Recruitment Status : Completed
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
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.
|Condition or disease|
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:
- Coagulation and thrombo-embolic events
- Infectious complications
|Study Type :||Observational|
|Actual Enrollment :||4995 participants|
|Official Title:||European Society Of Intensive Care Medicine COVID-19 Project (UNITE-COVID)|
|Actual Study Start Date :||July 1, 2020|
|Actual Primary Completion Date :||September 30, 2020|
|Actual Study Completion Date :||December 31, 2020|
- Number of patients admitted with confirmed COVID19 infection [ Time Frame: One day with 60 day follow-up ]Number of patients in the ICU on the study day
- Mortality (ICU) [ Time Frame: One day with 60 day follow-up ]Proportion of patients who have died at ICU discharge
- Mortality (60-day) [ Time Frame: One day with 60 day follow-up ]Proportion of patients who have died at day 60
- Duration of hospitalization in the ICU [ Time Frame: One day with 60 day follow-up ]Length of stay in the ICU
- Proportion of patients requiring invasive mechanical ventilation [ Time Frame: One day with 60 day follow-up ]Proportion of patients who require invasive mechanical ventilation during ICU stay versus all patients
- Proportion of patients developing infections during ICU stay [ Time Frame: One day with 60 day follow-up ]Proportion of patients who acquire an infection during their ICU stay versus all patients
- Proportion of patients developing thromboembolic events during ICU stay [ Time Frame: One day with 60 day follow-up ]Proportion of patients who develop any thromboembolic event during their ICU stay versus all patients
- Proportion of patients requiring tracheotomy during ICU stay [ Time Frame: One day with 60 day follow-up ]Proportion of patients who are require a tracheostomy versus all patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836065
|Ghent University Hospital|
|Ghent, Belgium, 9000|
|Principal Investigator:||Jan DE WAELE||University of Gent Hospital|