The RIsk Stratification in COVID-19 Patients in the ICU Registry (RISC-19-ICU)
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|ClinicalTrials.gov Identifier: NCT04357275|
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
The Risk stratification in COVID-19 patients in the ICU (RISC-19-ICU) registry was founded during the emerging SARS-CoV-2 pandemic. COVID-19 is a novel disease caused by infection with the SARS-CoV-2 virus that was first described in December 2019. The disease has spread exponentially in many countries and has reached global pandemic status within three months. According to first experience, hospitalization was required in approximately 20 % of cases and severe, life-threatening illness resulted in approximately 10 %. In some countries, health care systems were overwhelmed by the rapid increase in critically ill patients that far exceeded their capacity. It is thus of utmost importance to gain knowledge about the characteristics and course of critically ill patients with COVID-19 and to stratify these patients according to their risk for further deterioration. A key part of fighting this pandemic is to exchange scientific information and advance our understanding of the disease.
The Risk stratification in COVID-19 patients in the ICU (RISC-19-ICU) registry aims to collect an anonymized dataset to characterize patients that develop life-threatening critical illness due to COVID-19 and make it accessible to collaborative analysis.
The data collected may be composed of a core dataset and/or an extended dataset. The core dataset consists of a basic set of parameters, of which many are commonly generated during treatment of critically ill patients with COVID-19 in an intensive care unit (the individual parameters are marked yellow in the attached case report forms, and are clearly marked on the electronic case report forms during data entry). The extended dataset consists of parameters that may be measured during treatment of critically ill patients with COVID-19 in an intensive care unit, depending on clinical practice, indication and availability of the measurement method. The data accumulating in the registry as the pandemic or subsequent waves develop are made available to the collaborators to support an optimal response to the pandemic threat. The information gained on the initial characteristics and disease course via the RISC-19-ICU registry may contribute to a better understanding of the risk factors for developing critical illness due to COVID-19 and for an unfavorable disease course, and thus support informed patient triage and management decisions.
Initial research questions are (I) to perform risk stratification of critically ill patients with COVID-19 to find predictors associated with the development of critical illness due to COVID-19: characterization of the study population, which are critically ill patients with COVID-19: inflammation, oxygenation, circulatory function, among other parameters collected in the registry, and (II) to perform risk stratification of critically ill patients with COVID-19 to predict outcome after ICU admission (ICU mortality, ICU length of stay): characterization of patients grouped by disease course in the ICU, based on inflammation, oxygenation, circulatory function, and other parameters collected in the registry.
|Condition or disease||Intervention/treatment|
|Critical Illness ARDS Inflammatory Response COVID-19 Circulatory Shock||Other: ICU treatment|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||4 Weeks|
|Official Title:||The RIsk Stratification in COVID-19 Patients in the ICU Registry|
|Actual Study Start Date :||March 13, 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
|ICU admissions due to COVID-19||
Other: ICU treatment
ICU treatment according to standard of care
- ICU mortality [ Time Frame: During inclusion period ]
- Hospital mortality [ Time Frame: During inclusion period ]
- ICU length of stay [ Time Frame: During inclusion period ]
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): NCT04357275
|Contact: Matthias P Hilty, MD||+41 44 255 11 email@example.com|
|University Hospital of Zurich||Recruiting|
|Zurich, Switzerland, 8091|
|Contact: Dorothea Heuberger, PhD|
|Principal Investigator:||Matthias P Hilty, MD||RISC-19-ICU board|
|Study Chair:||Pedro D Wendel Garcia, MSc||RISC-19-ICU board|
|Study Chair:||Reto A Schüpbach, MD||RISC-19-ICU board|
|Study Chair:||Jonathan Montomoli, MD, PhD||RISC-19-ICU board|
|Study Chair:||Philippe Guerci, MD||RISC-19-ICU board|
|Study Chair:||Theirry Fumeaux, MD||RISC-19-ICU board|