FRESH Study Results Suggest New Parameter to Strengthen qSOFA Risk Assessment for Septic Patients

Cheetah Medical, a Massachusetts-based leader in non-invasive fluid management devices, today announced results of a sepsis data analysis leveraging Cheetah Medical technology. The findings were presented at the Society of Critical Care Medicine’s (SCCM) 48^th Critical Care Congress in San Diego, held from February 17-20, 2019. These data from the Fluid Responsiveness Evaluation in Sepsis-associated Hypotension (FRESH) study indicate that the sensitivity of the Quick Sepsis-related Organ Failure Assessment (qSOFA) can be further strengthened by adding a measure assessing cardiac risk.

qSOFA, a bedside test used to quickly identify suspected septic patients at greater risk for poor outcomes, does not currently test for cardiac dysfunction—a strong predictor of decreased survival rates in this population. Stroke volume (SV) change in response to Passive Leg Raise (PLR) is an effective method to predict fluid responsiveness (FR) and can help detect any underlying cardiac dysfunction. New findings from the FRESH study indicate that adding this method to the qSOFA assessment may improve its utility.

Led by Ivor Douglas, M.D., FRCP, Denver Health Medical Center, researchers evaluated the impact of assessing cardiac risk via fluid responsiveness in tandem with qSOFA on refining patient risk factors in septic shock. The investigators performed 548 PLR assessments over a 72-hour period in 72 septic patients (60% female, average age of 63). Patients were determined to be fluid responsive if SV increased more than 10 percent via PLR as measured by Cheetah Medical technology. The admission qSOFA scores for this cohort of PLRs were similar among Survivors [1.67 +/- 0.76 (1.46, 1.87)] and Non-Survivors [1.85 +/- 0.80 (1.42, 2.27), P=0.45]. However, restricting the analysis cohort by removing data points with PLRs predicting a high probability of cardiac dysfunction revealed a statistically significant difference between the admission qSOFA scores of Survivors [1.48 +/- 0.75 (1.41, 1.56)] and Non-Survivors [2.05 +/- 0.76, (1.86, 2.23), P<0.0001)].

“In patients with underlying cardiac dysfunction, qSOFA may lose some sensitivity to differentiate Survivors from Non-Survivors,” said Dr. Douglas. “Therefore, adding a measure that identifies high risk of cardiac dysfunction to qSOFA may help to further refine patient risk factors in septic shock. This insight is significant. Using stroke volume-based PLR may improve the overall assessment of patients beyond just assessing for fluid responsiveness. As a result, clinicians can make more informed treatment decisions for better patient outcomes.”

“Cheetah is proud to manufacture the technology that helped Dr. Douglas’ team identify ways to potentially improve sepsis survival rates via the FRESH study. We continually work to improve our fluid management monitoring tools and welcome this validation of their effectiveness in critical care settings,” said Chris Hutchison, president and CEO of Cheetah Medical.

About the FRESH Study
The Fluid Responsiveness Evaluation in Sepsis-associated Hypotension study (FRESH), which continues to enroll patients, is a prospective, randomized, controlled study evaluating the incidence of fluid responsiveness (FR) in critically ill patients with sepsis or septic shock. Upon completion, the FRESH study will assess the mean difference in fluid balance at intensive care unit (ICU) discharge and associated patient outcomes, based on a dynamic assessment of FR in septic patients with refractory hypotension in an ICU setting. Interim results are anticipated in mid-to-late 2019.

About Cheetah Medical
Cheetah Medical is the pioneer and leading global provider of 100 percent non-invasive fluid management monitoring technologies, designed for use in critical care, operating room and emergency department settings. The CHEETAH Starling™ SV is fast becoming the gold standard in fluid management, as it provides immediate, dynamic assessments of fluid responsiveness, enabling clinicians to make more confident and informed treatment for their patients. Moreover, recent research from the University of Kansas Medical Center has shown effective fluid management can reduce hospital ICU stays by an average of 2.89 days, reduce risk of mechanical ventilation and initiation of acute dialysis, saving over $14,000 in medical costs per patient. The company’s fluid management systems currently make an impact in more than 400 hospitals throughout the U.S. and in 30 countries worldwide.

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Maayan Wenderow
Cheetah Medical
(617) 964-0663
[email protected]

Melissa Baron
JPA Health Communications
(617) 657-1312
[email protected]