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Abstract: TH-PO984

A Prospective Clinical Study to EvaluAte the AbiliTy of the CloudCath System to Detect Peritonitis Compared to Standard of Care During In-Home Peritoneal Dialysis (CATCH)

Session Information

Category: Dialysis

  • 702 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • Mehrotra, Rajnish, University of Washington, Seattle, Washington, United States
  • Yu, Eric Hsiang, CloudCath Inc., San Francisco, California, United States
  • ElBadry, Aly, CloudCath Inc., San Francisco, California, United States
  • Fisher, Brian, CloudCath Inc., San Francisco, California, United States
  • Williamson, Don E., CloudCath Inc., San Francisco, California, United States
  • Chertow, Glenn, Stanford University School of Medicine, Stanford, California, United States
Background

Peritonitis has long been recognized as the leading complication of peritoneal dialysis. Current standard practice is to advise patients to monitor for signs of infection (abdominal pain and cloudy effluent). CloudCath developed a continuous monitoring device that pairs with CloudCath software to monitor turbidity changes in the effluent when peritonitis may be visually undetectable and asymptomatic.

Methods

We conducted a single arm, open label, multicenter outpatient study where study participants used the CloudCath system that had the notification capability deactivated so that neither participants nor investigators were aware of the device results. We measured the time between device detection of turbid fluid and the study participant presentation to the clinic/hospital with signs/symptoms of peritonitis.

Results

As of June 30, 2021, the Cloudcath system has been used by 185 participants for a total of 26,185 days and has analyzed 126,300 individual PD exchange cycles. A total of 28 participants presented to the clinic/hospital with 34 potential peritonitis events including 22 participants who experienced 26 peritonitis events that met ISPD criteria (>100 WBC/µl and > 50% PMN), 7 participants who experienced 8 events that did not meet ISPD criteria and 1 participant who experienced both. The median time from when the CloudCath system detected changes in turbidity scores to the time in which the participant presented to clinic/hospital was 4.5 days, (range < 0.2 to 15.4).

Conclusion

The present study demonstrates that the CloudCath system can detect changes in effluent turbidity scores that may prompt evaluation for peritonitis significantly earlier than current standard of care. The time gained by the early detection may allow for earlier diagnosis and treatment of peritonitis that may, in turn, reduce risk of peritonitis-related complications such as hospitalizations, PD catheter removals or permanent transfer to HD.

Funding

  • Commercial Support