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

May 22, 2019

NEWTON, Mass.--(BUSINESS WIRE)--May 22, 2019--

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 22 nd, 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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190522005153/en/

CONTACT: Maayan Wenderow

Cheetah Medical

(617) 964-0663

maayan@cheetah-medical.comKatie Dodge

JPA Health Communications

(617) 657-1304

KDodge@jpa.com

KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS TEXAS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES RESEARCH SCIENCE GENERAL HEALTH

SOURCE: Cheetah Medical

Copyright Business Wire 2019.

PUB: 05/22/2019 12:15 PM/DISC: 05/22/2019 12:15 PM

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