What are you talking about? There has been no US trial for treating sepsis with Cytosorb and Refresh 1 and Refresh 2 are both for cardiac surgery.
Are you thinking of the EU study that got them the CE mark? It's protocol was treatment for 6 hours/day for up to 7 days, I believe. That study was not powered to predict mortality.
The primary outcome measure of that study was: Relative IL-6 levels as a percent (%) of baseline will be lower in subjects receiving CytoSorb treatment in conjunction with the standard of care as compared to control subjects receiving only the standard of care for ARDS/ALI in the setting of sepsis.
From a PR on the study:
CytoSorbents had previously reported that the primary endpoint of the study had been achieved with an average IL-6 reduction of 49.1% (p = 0.01) across the 7-day treatment period. Analysis of other important cytokines demonstrated similar patterns of reduction including MCP-1 (-49.5%, p = 0.002), IL-1ra (-36.5%, p = 0.001) and IL-8 (-30.2%, 0.002) with additional cytokine analysis ongoing. These data further confirm the effectiveness of CytoSorb™ as a broad cytokine filter and its ability to reduce cytokine storm in patients with sepsis.
Age is one of the strongest predictors of death and is consistent with our own data showing that patients aged 65 years and older had a nearly 5-fold greater risk of death than younger patients. In these patients, CytoSorb™ treatment resulted in a statistically significant improvement in 14-day mortality (0% vs 36% control, p = 0.04, n = 21) with trends to benefit in 28-day mortality (40% vs 45% control), fewer mechanically ventilated patients at 28 days (60% vs 73% control), and improvements in MODS and APACHE 2 organ failure scores during treatment. These data suggest that 7 days of CytoSorb™ treatment is protective for up to 14 days in this elderly population and that longer treatment with CytoSorb™, beyond the 7-day treatment limitation of the trial, could yield even greater benefit to these patients.
As expected, there is also a good correlation between CytoSorb™ cytokine reduction and outcome in patients with highly elevated IL-6 levels (greater than or equal to 1,000 pg/mL) or IL-1ra (greater than or equal to 16,000 pg/mL) which are both known, independent predictors of mortality in sepsis. In these patients, CytoSorb™ treatment showed positive trends to benefit in 28-day all-cause mortality (0% vs 62.5% control, n = 14), fewer patients on mechanical ventilation at 28 days (33% vs 88% control), and fewer days in the ICU (23.8 vs 27.5 days control).
They conducted another dosing study after EU approval and that is where they started testing longer treatment duration, up to 24 hours. The small refractory septic shock study also took it a step further treating the moribund patients by swapping in new devices much earlier than 24 hours. The results of that study are pretty spectacular.
