Baxter International Inc. has announced that the peer-reviewed journal Blood Purification published a supplemental issue that features real-world clinical experience with the company’s Oxiris filter which can be used simultaneously in continuous renal replacement therapy (CRRT) and in the removal of cytokines and endotoxin to aide in the management of acute kidney injury (AKI) patients with sepsis.
“Caring for patients in the intensive care unit is changing due to new technologies and research becoming available,” said Kai Harenski, MD, medical affairs lead for Baxter's Acute Therapies business, in a news release. “When leading clinicians share real-world experiences of how they are using new therapeutic options like Oxiris, we can help increase scientific knowledge in a clinical area that is difficult to study.”
Among the nine manuscripts published in the new Blood Purification supplement, which Baxter sponsored, clinicians described filter technologies available today and shared clinical experiences when treating different types of patients.
The studies, which are being highlighted at the 37th Vicenza Course on AKI and CRRT in Italy, add to the body of scientific knowledge around the use of extracorporeal (outside the body) blood purification (EBP) to address critical conditions.
The use of EBP to remove cytokines and endotoxin from the blood represents a promising approach to treat patients with conditions where excessive levels of those inflammatory mediators are often seen including sepsis. While EBP continues to be studied for its potential to help address sepsis and other conditions, clinical research is particularly challenging in this setting, said Baxter, noting many failed clinical trials that explored the effect of EBP.
Baxter says it will support the creation of the OxirisNet registry with several Italian hospitals to track key treatment data for patients who receive a treatment with the Oxiris filter. The new registry will use a web-based platform specifically designed for research purposes and will be fed by clinical data that are prospectively collected.
In one manuscript, researchers in Italy performed a retrospective observational study including 50 patients who were treated with CRRT using the Oxiris set to address AKI and sepsis or septic shock. A second manuscript described a retrospective cohort study of 31 patients in France who had septic shock and AKI requiring CRRT combined with Oxiris.
Though their conclusions were limited by available data and study designs, Baxter says the researchers observed an association between treatment with Oxiris and certain improved clinical measures, such as hemodynamic status (reduction in lactate level and norepinephrine dose and increase in mean arterial pressure) and renal function, providing an important evidence base for clinicians using Oxiris in current practice. However, the company says additional data is needed to validate these real-world outcomes.
Baxter said it funded the logistics to publish and provide open access to the supplement, was involved in identifying its theme and potential contributors but not involved in creating the content except as contributing authors on certain manuscripts, which it asserts were independently reviewed.
