FRESH Study Results Demonstrates Fluid Responsiveness Is Dynamic During 72-Hour Sepsis Monitoring Window

Data analyses leveraging Cheetah Medical technology presented at the
2019 American Thoracic Society Conference (ATS)

NEWTON, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/ATS2019?src=hash” target=”_blank”gt;#ATS2019lt;/agt;–Cheetah Medical, a Boston-based leader in non-invasive fluid management,
today announced new results of two sepsis data analyses utilizing
Cheetah Medical technology. The findings were presented at the 2019
American Thoracic Society Conference (ATS), May 17-22 in Dallas, Texas.

These data are part of continued interim results from the completed
Fluid Responsiveness Evaluation in Sepsis-associated Hypotension (FRESH)
study and indicate that a septic patient’s fluid responsiveness state
may change over the first 72 hours. These interim results were presented
by lead investigator Ivor Douglas, M.D., FRCP, Denver Health Medical
Center, in poster sessions (P784
and P818).
Dr. Douglas will be present Wednesday, May 22nd, 9:15 a.m. –
1:00 p.m. ET to discuss these data.

“There is an accumulating body of evidence pointing to the importance of
fluid responsiveness and the highly dynamic and changing physiology of
the circulation during the critical initial 72 hours of therapy in
septic patients,” said Dr. Douglas. “Our studies highlight that
frequently checking fluid responsiveness can guide clinicians to ensure
that the IV fluid they give will be effective therapy – avoiding
unnecessary fluid and complications.”

“Interim data like these continue to validate our confidence in the
critical role fluid monitoring and management play in treating septic
patients,” said Chris Hutchison, President and CEO of Cheetah Medical.
“We look forward to sharing the complete results, anticipated later this
year.”

Physiology of Fluid Responsiveness in Sepsis – Abstract A6002 / P818

In this analysis, a total of 605 Passive Leg Raise (PLR) assessments
were performed in 84 patients over a 72-hour monitoring period. Patients
were separated into six different groups based on the percentage of
fluid responsiveness (FR) PLRs.

Results of this study found that patient’s FR changes frequently over
the first 72 hours of therapy in patients with septic shock. When used
to guide fluid therapy, measurement of FR should continue to occur over
the first 72 hours.

Within the subject group of this study, a small group of patients (SV
increased ≥ 10%) were always fluid responsive and another group of
patients was never fluid responsive. However, groups 3-5, which included
the majority of patients, exhibited FR rates between 5-75%.

Decreased Change in Stroke Volume in Patients with Sepsis and Septic
Shock – Abstract A6694 / P784

Utilizing the same 84 patients from the first analysis, this study also
observed a total of 605 Passive Leg Raise (PLR) assessments over a
72-hour monitoring period. Similarly, patients were split into six
different groups based on the percentage of fluid responsiveness (FR)
PLRs.

Key findings from this study indicate that patients who remain primarily
fluid non-responsive (pre-load independent) are more likely to
demonstrate negative PLRs which have been previously associated with
ECHO-confirmed LV/RV dysfunction. Specifically, within the subject group
of the trial, 17% of patients across the six groups exhibited a ΔSV<0 at least once after receiving initial resuscitation fluid of 2.3 (+/- 0.6) L.

About the FRESH Study

The Fluid Responsiveness Evaluation in Sepsis-associated Hypotension
study (FRESH) is a prospective, randomized, controlled study evaluating
the incidence of fluid responsiveness (FR) in critically ill patients
with sepsis or septic shock. The study completed enrollment on March 14,
2019 following successful primary outcomes. The objective of the FRESH
study is to 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
[email protected]

Katie Dodge
JPA Health Communications
(617) 657-1304
[email protected]

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