Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836065
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2020-06-25
Brief Title:
ESICM UNITE COVID-19 Project UNITE-COVID
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
European Society Of Intensive Care Medicine COVID-19 Project UNITE-COVID
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNITE-COVID
Brief Summary:
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
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:
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 underexplored 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
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 underexplored 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None