The RIsk Stratification in COVID-19 Patients in the ICU Registry (RISC-19-ICU)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Critical Illness; Inflammatory Response; ARDS; Circulatory Shock
• Intervention / Treatment: Other: ICU treatment

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Matthias P Hilty, MD; Phone Number: +41 44 255 11 11; Email: matthias.hilty@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital of Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an intensive care unit in a collaborating center due to COVID-19

Description

Inclusion Criteria:

• Admission to an intensive care unit in a collaborating center due to COVID-19

Exclusion Criteria:

• Missing ethical approval

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU admissions due to COVID-19	Other: ICU treatment; ICU treatment according to standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ICU mortality	During inclusion period

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital mortality	During inclusion period
ICU length of stay	During inclusion period

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: 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

Publications and helpful links

General Publications

• Wendel-Garcia PD, Moser A, Jeitziner MM, Aguirre-Bermeo H, Arias-Sanchez P, Apolo J, Roche-Campo F, Franch-Llasat D, Kleger GR, Schrag C, Pietsch U, Filipovic M, David S, Stahl K, Bouaoud S, Ouyahia A, Fodor P, Locher P, Siegemund M, Zellweger N, Cereghetti S, Schott P, Gangitano G, Wu MA, Alfaro-Farias M, Vizmanos-Lamotte G, Ksouri H, Gehring N, Rezoagli E, Turrini F, Lozano-Gomez H, Carsetti A, Rodriguez-Garcia R, Yuen B, Weber AB, Castro P, Escos-Orta JO, Dullenkopf A, Martin-Delgado MC, Aslanidis T, Perez MH, Hillgaertner F, Ceruti S, Franchitti Laurent M, Marrel J, Colombo R, Laube M, Fogagnolo A, Studhalter M, Wengenmayer T, Gamberini E, Buerkle C, Buehler PK, Keiser S, Elhadi M, Montomoli J, Guerci P, Fumeaux T, Schuepbach RA, Jakob SM, Que YA, Hilty MP; RISC-19-ICU Investigators. Dynamics of disease characteristics and clinical management of critically ill COVID-19 patients over the time course of the pandemic: an analysis of the prospective, international, multicentre RISC-19-ICU registry. Crit Care. 2022 Jul 4;26(1):199. doi: 10.1186/s13054-022-04065-2.
• Hilty MP, Moser A, David S, Wendel Garcia PD, Capaldo G, Keiser S, Fumeaux T, Guerci P, Montomoli J, Van Boeckel TP, Jeitziner MM, Que YA, Jakob S, Schupbach RA; RISC-19-ICU Investigators for Switzerland. Near real-time observation reveals increased prevalence of young patients in the ICU during the emerging third SARS-CoV-2 wave in Switzerland. Swiss Med Wkly. 2021 Jul 21;151:Swiss Med Wkly. 2021;151:w20553. doi: 10.4414/smw.2021.20553. eCollection 2021 Jul 19.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 18, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Shock; Critical Illness
• Other Study ID Numbers: KEK-ZH-req-2020-00322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Each collaborator's data is available for their own use; The collaborators are encouraged to share their analysis code (the standard is R code); Analysis on the entire registry dataset may be performed using the same analysis pathway. To request analysis on the entire dataset, a protocol may be submitted to the board; The board may make some descriptive data publicly available to support the coordination of the response to the pandemic threat; Scientific findings will be jointly published in a scientific journal according to a collaboration agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No