Friday, September 15, 2017 8:03:55 PM
"So, there has been now a very widely public sized study called the vitamin C trial and this is a trial that was reported on earlier this year. It's a vitamin C, hydrocortisone and thiamine trial. And this was a retrospective single center 47 consecutive patient trial in patients with severe sepsis or septic shock that were given daily treatments of 6 grams of IV vitamin C, 200 milligrams of hydrocortisone IV for 7 days. It's very similar to the CORTICUS as well as the HYPRESS trials, and 400 milligrams of IV thiamine each day.
And they compared this against a same center 47 consecutive patient historical control, and what they found was that hospital mortality was roughly 40% in the control versus 8.5% in the treated, and if you go back to the HYPRESS trial that was roughly the overall mortality that they saw in patients with no shock.
But although this is interesting data supported by a real mechanism of action, it is limited by the fact that it is a single center non-randomized controlled study. And when you look at the patients, they are very different from the patients that are typically in septic trials. For example in most of our trials that we do, patients typically have multi-organ failure with on mechanical ventilation, many are on dialysis, most of them have septic shock.
But in this particular study, they had a relatively low severe illness with only about 22% in each group having septic shock requiring vasopressors, and in addition most only required a very short duration of use, approximately two days even in the controlled group. In addition only about a quarter of the patients required mechanical ventilation as well as most patients also have evidence of just modest perfusion deficits with lactate of about 3 millimoles per liter in both the treatment and the control.
And on top of that, there was a very short ICU stay, roughly a mean ICU stay about four days in both groups. The most trials in severe sepsis and septic shock, particularly septic shock most patients were in the ICU for 12 to 18 days on average. And so, the fact that the control group left the ICU after four days, again suggested they were relatively not very sick. So I think that although this is very interesting data and that it certainly justifies a larger multi center randomized control trial, we view this as a technology that is potentially complementary to our technology, but certainly nothing that what they've shown today would make our technology redundant.
So, why do we believe that? It is because that CytoSorb attack sepsis broadly. Now, the value of steroids and vitamin C is to try to help for maintain the capillary barrier against leakage, so try to prevent capillary leak syndrome as well as to allow the blood vessel to respond to vasopressors and to have good vasomotor tone, which is one of the things that is missing in patients with septic shock. An early goal directed therapy was trying to take up patients with fluid and make sure that their tissues were receiving adequate amounts of blood as well as oxygen.
And so, all of these studies including the ones on that table that I just presented to you, typically focus on sepsis in one avenue that is gone wrong. But when you look at a sepsis patient, it's typically many, many things that are going wrong at the same time. It’s kind of a system crashing all at ones. And one of the benefits to CytoSorb is that we attack sepsis broadly. So we have very good data that CytoSorb reduces inflammatory cytokine and other factors that are perpetuating a hyper inflammatory response that is leading to organ failure and death."
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