The RIsk Stratification in COVID-19 Patients in the ICU Registry

Summary

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.

Conditions

• Critical Illness
• ARDS
• Inflammatory Response
• COVID-19
• Circulatory Shock

Interventions

OTHER

ICU treatment

ICU treatment according to standard of care

Sponsors & Collaborators

• University of Zurich

  lead OTHER

Principal Investigators

• Matthias P Hilty, MD · RISC-19-ICU board

• Pedro D Wendel Garcia, MSc · RISC-19-ICU board

• Reto A Schüpbach, MD · RISC-19-ICU board

• Jonathan Montomoli, MD, PhD · RISC-19-ICU board

• Philippe Guerci, MD · RISC-19-ICU board

• Theirry Fumeaux, MD · RISC-19-ICU board

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-13

Primary Completion

2022-12-31

Completion

2025-12-31

Countries

• Switzerland

Study Locations