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Baxter Announces New Research on 3-in-1 Oxiris Set for CRRT and Sepsis Management

Pressemeldinger

  • Blood Purification supplement includes studies on real-world use of Oxiris to treat patients in the intensive care unit (ICU)

  • Studies add to scientific exchange on the role of blood filtering technology to address critical conditions

  • Patient registry is being started to generate additional evidence on Oxiris

DEERFIELD, Ill. -

Baxter International Inc. (NYSE: BAX), a global leader in acute care therapies, announced today that the peer-reviewed journal Blood Purification published a supplemental issue sponsored by Baxter 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. The studies, which are being highlighted at the 37th Vicenza Course on AKI and CRRT in Italy this week, 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, a serious medical condition that affects up to 40 percent of critically ill patients in the ICU.1-7 While EBP continues to be studied for its potential to help address sepsis and other conditions, clinical research is particularly challenging in this setting. In fact, many clinical trials that explored the effect of EBP have failed to demonstrate consistent results due to the complexity of patient cases, among other factors. To help address these limitations, Baxter intends to 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.

“Caring for patients in the intensive care unit is changing due to new technologies and research becoming available,” said Kai Harenski, M.D., medical affairs lead for Baxter's Acute Therapies business. “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, clinicians described filter technologies available today and shared clinical experiences when treating different types of patients. 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, 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.

Additional data is needed to validate these real-world outcomes. Harenski added, “Baxter will continue to invest in generating evidence to better understand and advance scientific knowledge of the latest clinical research as part of our vision to transform care for patients in the ICU.”

Baxter funded the logistics to publish and provide open access to the supplement and was involved in identifying its theme and potential contributors. However, manuscripts were independently reviewed and Baxter was not involved in creating the content except as contributing authors on certain manuscripts.

About Baxter

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.

 

This release includes forward-looking statements concerning Baxter and its Oxiris set, including Oxiris’ indications, use, effectiveness and risks and expectations with regard to its availability in countries in Europe, the Middle East, Africa, Asia Pacific and other countries in the future and Baxter’s ability to generate additional clinical evidence supporting the use of Oxiris. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply issues; patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

 

Baxter and Oxiris are trademarks of Baxter International Inc. or its subsidiaries.

1. Pavon A, Binquet C, Kara F, et al. Profile of the risk of death after septic shock in the present era: an epidemiologic study. Crit Care Med. 2013;41:2600-2609.

2. Blanco J, Muriel-Bombin A, Sagredo V, et al. Incidence, organ dysfunction and mortality in severe sepsis: a Spanish multicentre study. Crit Care. 2008;12:R158.

3. Engel C, Brunkhorst FM, Bone HG, et al. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive Care Med. 2007;33:606-618.

4. Finfer S, Bellomo R, Lipman J, French C, Dobb G, Myburgh J. Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med. 2004;30:589-596.

5. Karlsson S, Varpula M, Ruokonen E, et al. Incidence, treatment, and outcome of severe sepsis in ICU-treated adults in Finland: the Finnsepsis study. Intensive Care Med. 2007;33:435-443.

6. Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014;311:1308-1316.

7. Sjoding MW, Prescott HC, Wunsch H, Iwashyna TJ, Cooke CR. Longitudinal changes in ICU admissions among elderly patients in the United States. Crit Care Med. 2016;44:1353-1360.