US-based critical care company CytoSorbents has enrolled first patients in the PROCYSS trial evaluating CytoSorb to reverse refractory septic shock (RSS).
PROCYSS is a randomised controlled trial (RCT) designed to evaluate the ability of CytoSorb to restore hemodynamic stability in patients with RSS.
The study is expected to enrol up to 160 patients at 20 sites across in Germany, and is anticipated to be completed by the end of 2023.
The first patient was enrolled at the University Hospital Hamburg Eppendorf in Germany, by the PROCYSS trial lead investigator, professor Stefan Kluge.
Stefan Kluge said: “Reversal of shock via hemodynamic stabilization is a top priority in the management of patients with RSS, and effective therapies are urgently needed to accomplish this critical therapeutic goal.
“Prolonged hypotension leads to tissue and organ ischemia, and can ultimately cause irreversible organ injury and death.
“Because of this, we are very pleased to lead and enroll the first patient in the PROCYSS randomized controlled trial, to evaluate CytoSorb for this application.
“By defining the patient population using specific criteria and standardizing who to treat and how to treat, we expect PROCYSS to help refine the use of CytoSorb in this extremely sick and difficult to manage patient population.”
RSS is characterised by persistently low mean arterial blood pressure, regardless of fluid resuscitation and high dose vasopressor use, seen in patients with fatal infection and sepsis.
CytoSorbents said that severe hyperinflammation contributes to RSS, and majority of patients suffering from RSS would die, despite of standard of care therapy.
Removal of inflammatory mediators using CytoSorb blood purification, has showed promise in real-world clinical usage, and is now being evaluated in PROCYSS, said the company.
It was approved in the European Union (EU), and is distributed in more than 70 countries around the world as an extracorporeal cytokine adsorber.
CytoSorbents is focused on treating life-threatening conditions in the intensive care unit and cardiac surgery using blood purification using its unique polymer adsorption technology.
CytoSorbents chief medical officer Efthymios Deliargyris said: “PROCYSS is a landmark trial, and the enrollment of the first patient represents another important milestone as we continue to execute our global clinical plan.
“We remain steadfast in our commitment to invest in rigorous company-sponsored trials to generate the high-quality evidence needed to inform the global critical care community on how CytoSorb therapy can address areas of high unmet medical need, such as sepsis.
“Next in line is the COSMOS Registry, an international prospective registry expected to capture real-world use of CytoSorb across multiple critical care applications that is scheduled to begin enrollment in the first half of 2022.”
