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

Data analysis leveraging Cheetah Medical technology presented at the 48th
Critical Care Congress in San Diego

NEWTON, Mass.–(BUSINESS WIRE)–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) 48th 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.

Contacts

Maayan Wenderow
Cheetah Medical
(617) 964-0663
maayan@cheetah-medical.com

Melissa Baron
JPA Health Communications
(617) 657-1312
mbaron@jpa.com

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