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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
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.


Condition or disease Intervention/treatment
Critical Illness ARDS Inflammatory Response COVID-19 Circulatory Shock Other: ICU treatment

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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




Primary Outcome Measures :
  1. ICU mortality [ Time Frame: During inclusion period ]

Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: During inclusion period ]
  2. ICU length of stay [ Time Frame: During inclusion period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Missing ethical approval

Information from the National Library of Medicine

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


Contacts
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Contact: Matthias P Hilty, MD +41 44 255 11 11 matthias.hilty@usz.ch

Locations
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Switzerland
University Hospital of Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Dorothea Heuberger, PhD         
Sponsors and Collaborators
University of Zurich
Investigators
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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
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04357275    
Other Study ID Numbers: KEK-ZH-req-2020-00322
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Shock
Disease Attributes
Pathologic Processes