The COSMOS Registry of CytoSorb Hemoadsorption Therapy in Critically Ill Patients: Protocol for an International, Prospective Registry (Preprint)

Abstract

BACKGROUND Extracorporeal blood purification with CytoSorb® has been widely used as an adjunctive therapy in several hyperinflammatory critical care conditions as well as to remove elevated levels of myoglobin or bilirubin in patients with rhabdomyolysis or liver failure. OBJECTIVE The COSMOS (CytOSorb TreatMent Of Critically Ill PatientS) Registry will provide a data repository and reporting infrastructure for the surveillance of CytoSorb® use in real-world critical care settings and serve as a comprehensive resource to assess the effects of such therapy on patients’ management. METHODS The Registry is collecting prospective data for patients treated with CytoSorb® during routine care in various critical care indications, based on the decision of the treating physicians. Data are collected at baseline, during CytoSorb® Therapy, 24 hours thereafter, at discharge from the Intensive Care Unit (ICU), hospital and on day 90. Main outcomes are change in inflammatory biomarkers, vasopressor requirements, fluid balance, organ function and organ support, length of ICU and hospital stay, occurrence of adverse events and mortality. RESULTS The COSMOS Registry is actively enrolling in multiple countries with an estimated initial readout planned for presentation at an international Critical Care conference in 2024. CONCLUSIONS The COSMOS Registry is intended to provide comprehensive real-world data on patient out-comes with CytoSorb® in various critical care indications thereby contributing to optimization of patient selection, timing of initiation, and dosing of hemoadsorption treatment. CLINICALTRIAL COSMOS Registry is registered on ClinicalTrials.gov with ID# NCT05146336.