CytoSorb hemoadsorption shows no benefit and potential harm in small septic shock trial
Photo by National Institute of Allergy and Infectious Diseases / Unsplash
Key Takeaway
Interpret CytoSorb trial in septic shock with extreme caution due to small size and concerning survival signals.
This single-center randomized controlled trial enrolled 31 adult patients with septic shock, an extracorporeal circuit, and interleukin-6 levels >500 pg/mL. Patients were randomized to receive standard care according to sepsis guidelines (n=17) or standard care plus CytoSorb hemoadsorption (n=14). The primary outcome was cumulative norepinephrine dose over 72 hours, which showed no significant difference between groups (control: 78 mg, intervention: 100.7 mg; P=0.09).
Secondary outcomes raised significant concerns. Survival at 48 hours was 100% (17/17) in the control group versus 64% (9/14) in the intervention group (P=0.01). Survival at 72 hours was 94% (16/17) in controls versus 57% (8/14) with CytoSorb (P=0.03). The total vasopressor dose per hour alive in the first 72 hours was significantly lower in the control group (1.2 mg vs. 2.5 mg; P=0.0053). The intervention group also had significantly lower lymphocyte percentages during the first 3 days (P=0.04).
Key limitations include the very small sample size, single-center design, and short 72-hour follow-up period. The study was not powered to detect differences in mortality, and the survival signals, while statistically significant, are from a tiny cohort. The mechanism behind the potential harm is unclear, though the observed immunomodulation (lower lymphocyte percentages) may be relevant.
For clinical practice, these results do not support the use of CytoSorb hemoadsorption in this specific septic shock population. The concerning survival and hemodynamic signals suggest potential harm, though the small size precludes definitive conclusions. This evidence should not change current standard care and highlights the need for cautious interpretation of small, single-center device trials.
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View Original Abstract ↓
BACKGROUND: Immune dysregulation and excessive cytokine release characterize the early phase of septic shock. Extracorporeal hemoadsorption with the CytoSorb device aims to restore immune balance by removing inflammatory mediators. Currently, clinical benefits remain uncertain.
METHODS: In a single-center randomized controlled trial, 31 adult patients with septic shock, extracorporeal circuit, and interleukin-6 >500 pg/mL were included. The control group received standard care according to sepsis guidelines. The intervention group received standard care plus CytoSorb hemoadsorption. The primary outcome was the cumulative norepinephrine dose over 72 hours. Secondary outcomes included clinical and immunological endpoints.
RESULTS: Between February 2022 and July 2023, 58 patients with septic shock and hyperinflammation were screened for study inclusion. Seventeen patients were randomized to the control group, and 14 patients received extracorporeal cytokine removal. Hemoadsorption started within 24 hours after the onset of septic shock in 93% of cases. The cumulative norepinephrine dose in 72 hours was 78 mg (52.7-117.8 mg) in the control group and 100.7 mg (66.4-190.8 mg) with extracorporeal cytokine removal ( P = 0.09). The total vasopressor dose per hour alive in the first 72 hours was significantly lower in the control group compared with extracorporeal hemoadsorption (1.2 mg, 0.8-2.0 mg vs . 2.5 mg, 1.7-3.3 mg; P = 0.0053). Survival at 48 hours (100%, n = 17/17 vs . 64 %, n = 9/14; P = 0.01) and 72 hours (94%, n = 16/17 vs . 57%, n = 8/14; P = 0.03) after onset of septic shock was higher in the control group. Intensive care unit mortality, length of stay, duration of septic shock, and other clinical outcomes did not differ between the groups. The humoral immune response, including pro- and anti-inflammatory cytokines, was similar between groups. Compared with controls, patients with extracorporeal cytokine removal had significantly lower lymphocyte percentages during the first 3 days of septic shock (6.2%, 5.0% - 17.4% vs. 2.5%, 2.1% - 5.6%; P = 0.04), whereas leukocyte and lymphocyte subsets as well as cytotoxic capacities were not altered by hemoadsorption.
CONCLUSIONS: Early initiation of extracorporeal hemoadsorption in patients with septic shock did not improve vasopressor requirements or clinical outcomes, and no effects on the immune response were observed.
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