GINOP - STAY ALIVE(GINOP-2.3.2-15-2016-00048) Funder: Nemzeti Kutatási, Fejlesztési
és Innovációs Hivatal
Sepsis and septic shock have mortality rates between 20% and 50%. In sepsis, the immune
response becomes dysregulated, which leads to an imbalance between proinflammatory
and anti-inflammatory mediators. 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 adsorption
with a device called CytoSorb. This study aims to compare the efficacy of standard
medical therapy and continuous extracorporeal cytokine removal with CytoSorb therapy
in patients with early refractory septic shock. Furthermore, we compare the dosing
of CytoSorb adsorber device changed every 12 or 24 hours.It is a prospective, randomised,
controlled, open-label, international, multicentre, phase III study. Patients fulfilling
the inclusion criteria will be randomly assigned to receive standard medical therapy
(group A) or-in addition to standard treatment-CytoSorb therapy. CytoSorb treatment
will be continuous and last for at least 24 hours, CytoSorb adsorber device will be
changed every 12 (group B) or 24 hours (group C). Our primary outcome is shock reversal
(no further need or a reduced (≤10% of the maximum dose) vasopressor requirement for
3 hours) and time to shock reversal (number of hours elapsed from the start of the
treatment to shock reversal).Based on sample size calculation, 135 patients (1:1:1)
will need to be enrolled in the study. A predefined interim analysis will be performed
after reaching 50% of the planned sample size, therefore, the corrected level of significance
(p value) will be 0.0294.Ethics approval was obtained from the Scientific and Research
Ethics Committee of the Hungarian Medical Research Council (OGYÉI/65049/2020). Results
will be submitted for publication in a peer-reviewed journal.NCT04742764; Pre-results.
