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ESICM UNITE COVID-19 Project (UNITE-COVID)

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

COVID-19 Infection

Study type

Observational

Funder types

Other

Identifiers

NCT04836065
ESICMUNITE2020

Details and patient eligibility

About

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.

Full description

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:

  1. Center data (to be completed once)
  2. 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:

  1. Respiratory
  2. Coagulation and thrombo-embolic events
  3. Infectious complications
  4. Rehabilitation
  5. Renal

Enrollment

4,995 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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