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 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.
1. In short, what are the main goals of the RISC-19-ICU registry?
To collaboratively collect a standardized dataset of critically ill patients infected with SARS-CoV-2 to support an optimal response to the pandemic threat in near real-time through risk stratification
To enable all collaborators to not only learn from their own data, but to harness the combined experience of all ICUs around the world, both during the crisis, and thereafter
2. What is the target population?
Patients admitted to a collaborating center with SARS-CoV-2 infection confirmed according to the WHO guidelines
Targeted Centers: ICU centers, non-ICU centers treating patients with high-flow oxygen therapy or non-invasive ventilation
3. What data is collected?
The 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 parameters are listed in Annex.
Only anonymized data is entered into the registry. The data stored in the registry are considered non-identifiable.
4. What ethical considerations are required to participate in the registry?
The RISC-19-ICU registry protocol has been examined by the ethical committee of the Canton of Zurich, Switzerland and as collection of anonymized data, deemed exempt from further ethical approval.
Collaborating centers are advised to check for compliance with local ethical guidelines and legislation
5. What are my benefits when participating in the registry?
Each collaborator’s data is directly available for their own un-restricted use
One of the main purposes of the RISC-19-ICU registry is to enable collaborative data analysis. Thus collaborators may propose analysis on the entire dataset of the registry via a short proposal to the registry board
Findings may be jointly published in a scientific journal. All collaborating centers may designate up to two co-authors in addition to the board who, provided they have contributed to the publication, are co-authors as well. The collaborating center responsible for the sub-analysis (submitting the proposal) may propose the first and senior author of the publication.
6. Initial Research Questions that are explored during the emerging pandemic to assist the response to the ongoing crisis
Risk stratification and characterization of critically ill patients with COVID-19 to find predictors associated with the development of critical illness due to COVID-19: inflammation, oxygenation, circulatory function, other
Risk stratification of critically ill patients with COVID-19 to predict outcome after ICU admission: characterization of patients grouped by disease course in the ICU based on several parameters (inflammation, oxygenation, circulatory function, other)
7. What parameters may be entered into the eCRF?
All parameters are optional and are collected if they have been measured during routine clinical management. Additional non-identifying parameters to be added to the eCRF may be proposed by collaborators.
Patient Characteristics at Admission
Age, Weight, Height, Gender, Smoking History, Is Patient Health-Worker, Date Of Hospitalization, Transferred From (ER/ Normal Ward/ IMC/ Other ICU), NIV Before Transfer, Date Of ICU Admission, Date Of First Symptoms, Date Of First Diagnosis, Viral Load, Symptoms, Clinical Signs, Previous Medication, Frailty Index, COVID Exposure History, Comorbidities, Temperature, Hematocrit, Sodium, Potassium, Calcium, Chloride
ICU parameters (Day 0, 1, 2, 3, 5, 7, optionally Days 9 - 25)
GCS, Estimated Urine Output, Chest Auscultation, Cold Periphery, Cyanosis, Capillary Refill Time, Mottling Score, Circulatory Shock, Heart Rate, Respiratory Rate, Temperature, Systolic, Mean And Diastolic Arterial Pressure, Central Venous Pressure, Spo2, Norepinephrine, Epinephrine, Dobutamine, Milrinone, Vasopressin, Cardiac Index, EVLWI, PVPI, Pulmonary Artery Pressure, Pulmonary Artery Occlusion Pressure, Sao2, Scvo2, Svo2, Ventilation Mode, Tidal Volume, Plateau Pressure, Peak Inspiratory Pressure, PEEP, Autopeep, Etco2, ECMO Blood Flow, ECMO Fio2, ECMO Air Flow, Prone Position, Thorax Radiography Abnormalities, Computed Tomography Abnormalities, LVEF, Po2, Pco2, pH, HCO3-, Lactate, Respiratory Support, Organ Support Therapies, Liters O2 / Fio2, Leucocytes, Lymphocytes, Neutrophils, Thrombocytes, Erythrocyte Count, Hb, Hct, INR, Aptt, PT, Fibrinogen, D-Dimer, CRP, PCT, IL-6, LDH, Serum Ferritin, Total Bilirubin, ASAT, ALAT, GGT, AP, Albumin, Creatinine, Urea, CK, Myoglobin, Troponin, BNP, Viral Load, Fluid Balance, Urine Output, Furosemide, Infusion Volume, Blood Products, Sedation And Relaxation Drugs
ICU discharge / Outcome
Patient ALIVE At ICU Discharge, Date Of ICU Discharge, Date Of Hospital Discharge, Patient ALIVE At Discharge, 28d, 3mt, 6mt, Withdrawal Of Life Sustaining, Therapies, Complications, Organ Support Therapies, Antibiotics, Antifungals, Antivirals, Lowest PF Ratio, AKI, Bacterial, Fungal Superinfection, Microbiology Culture Results, Dates/Duration/Kind Of (Vasopressor Therapy/ Oxygen Supplement/ Mechanical Ventilation/ Tracheotomy/ CRRT/ ECCO2R/ ECMO/ Prone Position), Experimental Therapies (Type, Dose, Intervals, Overall Time), Corticosteroids