drugset / Trial / NCT04742764

Extracorporal Cytokin Removal in Septic Shock: a Prospective, Randomized, Multicenter Clinical Trial

NCT04742764

Phase 3 Suspended 135 enrolled University of Pecs
RandomizedParallel-groupSingle-blindTreatment

Summary

Sepsis and septic shock have mortality rates between 20-50%. When standard therapeutic measures fail to improve patients' condition, additional therapeutic alternatives are applied to reduce morbidity and mortality. One of the most recent alternatives is extracorporeal cytokine hemoadsorption. One of the most tested devices is CytoSorb, however, there are a lot of open questions, such timing, dosing and of course its overall efficacy. This study aims to compare the efficacy of standard medical therapy (Group A, SMT) and continuous extracorporeal cytokine removal with CytoSorb therapy in patients with early refractory septic shock. Furthermore, we compare the dosing of CytoSorb adsorber device - as the cartridge will be changed in every (12 Group B) or 24 hours (Group C).

Timeline

Start
2024-01-01
Primary completion
2026-10-31
Completion
2027-10-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background Dobutamine Small molecule
Background Norepinephrine Other / unclassified