Baxter Presents Critical Care Data at 34th Annual European Society of Intensive Care Medicine LIVES Congress

• Data supports the need for personalized approaches to care for critically ill patients with acute kidney injury (AKI) or sepsis
• Two Baxter-sponsored symposia feature expert perspectives on digital transformation in the intensive care unit and individualized fluid management

Baxter International Inc. (NYSE:BAX), a global leader in acute care, announced the presentation of data from three critical care studies at the 34^th Annual European Society of Intensive Care Medicine (ESICM) LIVES virtual congress taking place Oct. 3 – Oct. 6, 2021.

“Baxter is dedicated to advancing research that helps clinicians optimize care and improve outcomes for the most critically ill patients, including those with acute kidney injury and sepsis,” said Reaz Rasul, general manager of Baxter’s Acute Therapies business. “We are proud to participate in scientific exchange at meetings like ESICM and remain focused on driving innovation that supports patient needs across the care continuum and enables efficiencies in the intensive care unit.”

In one Baxter-sponsored study, investigators found that persistent severe acute kidney injury (PS-AKI) is prevalent among hospitalized adults in the United States and is associated with a significantly higher risk of death during hospitalization, as well as readmissions, dialysis and death during 30-day follow-up, compared to non-persistent AKI. Baxter also presented findings from its sub-analysis of the Fluid Response Evaluation in Sepsis Hypotension and Shock (FRESH) clinical trial patient population evaluating patients’ true baseline creatinine levels (prior to hospitalization). The sub-analysis demonstrated that analyzing patient creatinine levels and fluid responsiveness may help preserve kidney function and decrease the risk of AKI in the septic patient population. FRESH is a prospective, randomized global clinical trial that analyzed fluid management in adults with septic shock and demonstrated the benefits of using dynamic measurements to guide fluid therapy decisions for these patients.

Epidemiology and Clinical Outcomes of Persistent Severe AKI (Abstract #000145)

PS-AKI, a potentially life-threatening condition where kidney injury lasts for three or more days, may be an important determinant of patient outcomes. This study, conducted in collaboration with Premier Applied Sciences^® (PAS) and bioMérieux (EPA:BIM), compared characteristics and outcomes for patients with stage 2 or 3 AKI, according to KDIGO (Kidney Disease Improving Global Outcomes) criteria, who developed PS-AKI vs. those who did not (NPS-AKI). This retrospective observational study of 126,528 hospitalized U.S. adults was conducted using the Premier^® Healthcare Database (PHD) from Jan. 1, 2017 – Dec. 31, 2019, with 30-day follow-up for outcomes and a 12-month look-back period for baseline serum creatinine levels and comorbidities, including the Charlson Comorbidity Index. Adjusted for patient, clinical and hospital characteristics, patients with PS-AKI had 1.79 times higher odds of death than patients with NPS-AKI during index hospitalization (p<0.0001). During 30-day follow-up, adjusted odds for PS-AKI vs. NPS-AKI were 7% higher for readmissions, 23% higher for deaths, 10.7 times higher for dialysis and 6.8 times higher for patients who had never been on dialysis previously (p ≤ 0.01 for all).

Baxter and bioMérieux previously announced an agreement to develop and distribute a test to measure the CCL14 biomarker to help improve identification of and personalize treatment for patients at risk of PS-AKI.

Fluid Responsiveness and Creatinine Increase in Patients with Septic Shock (Abstract #000338)

This Baxter-sponsored sub-analysis of the FRESH clinical trial patient population compared patients’ true baseline creatinine levels (prior to hospitalization) to creatinine levels over the course of hospitalization. The findings demonstrated that analyzing patient creatinine levels and fluid responsiveness may help preserve kidney function and decrease the risk of AKI in the septic patient population. Patients with septic shock may be vulnerable to conditions like AKI, and high creatinine levels may indicate that the kidneys are not working properly. Study investigators evaluated 83 patients randomized to the intervention arm who were assessed for fluid responsiveness using Baxter’s Starling Fluid Management Monitoring System before further treatment was administered, and 41 patients randomized to the control arm who received usual care. Patients in the intervention arm received less fluid over a 72-hour period (3354.2 ± 2179.6) compared to the control arm (4721.3 ± 3319.1, p=0.007). Patients in the intervention arm displayed a statistically significant decrease in the need for renal replacement therapy (RRT) to remove fluid and toxins (5.1% vs 17.5%, p= 0.04). Additionally, this sub-analysis showed that 25.9% of patients in the intervention arm exhibited a two-fold increase in creatinine over their true baseline levels, compared to 48% of patients in the control arm (p=0.04).

Additionally, Baxter presented an abstract at ESICM titled “Fluid Responsiveness and Vasopressor Use in Patients with Septic Shock” (Abstract #000340), that further evaluated the administration of vasopressors (drugs used to constrict the blood vessels and raise blood pressure) in the FRESH patient population. The findings suggest that administering fluid only when it is effective at improving perfusion (the passage of fluids through the blood vessels) may lead to improved patient outcomes and does not increase the need for vasopressors and time on treatment.

Starling is currently approved in more than 30 markets globally.

Addressing Key Topics in Critical Care

Baxter sponsored two symposia at ESICM to advance dialogue on important issues:

• “Digital Transformation in the Intensive Care Unit (ICU): What’s Next” featured digital health experts sharing their perspectives on how innovation is fueling quality improvements in data-driven continuous renal replacement therapy (CRRT).
• “Fluid Management Wherever You Are” featured a panel of clinical experts discussing best practices for personalized fluid management across different settings, including in the hospital, in the ICU and during the perioperative period.

   

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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 90 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 potential benefits associated with analyzing patient creatinine levels and fluid responsiveness and Baxter’s Starling product. 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: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or 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 Starling are registered trademarks of Baxter International Inc.

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