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

NCT04357275 | Unknown DMC

• 1 other identifier: KEK-ZH-req-2020-00322
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  During inclusion period

Secondary Outcomes (2)

• Hospital mortality

  During inclusion period

• ICU length of stay

  During inclusion period

Study Arms (1)

ICU admissions due to COVID-19

Other: ICU treatment

Interventions

ICU treatment OTHER

ICU treatment according to standard of care

ICU admissions due to COVID-19

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Missing ethical approval

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 35787726 DERIVED

• 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.

  PMID: 34291810 DERIVED

MeSH Terms

Conditions

Critical Illness; COVID-19; Shock

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Matthias P Hilty, MD

  RISC-19-ICU board

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 22, 2020
• Study Start: March 13, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 1, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)