This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care. Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider. Following enrollment, Study Participants will use the CloudCath System for 12 continuous months. Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
314
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.
Dialysis Center of Western Massachusetts Llc
Chicopee, Massachusetts, United States
RECRUITINGTime to peritonitis diagnosis
The time between detection by the CloudCath System and laboratory confirmation of peritonitis.
Time frame: 12-months
Agreement in peritonitis detection between the CloudCath System and clinical criteria.
clinical criteria include: white blood cells (WBC) (\>100 cells per microliter or \>0.1 x10\^9/L), polymorphonuclear cells (PMN) (\>50%), microbiology culture results, gram staining, and peritonitis symptoms
Time frame: 12-months
Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis
Clinically actionable events defined as an event which requires treatment (i.e., prescribing medications, cleaning an exit site, etc) or intervention (i.e., PD catheter manipulation, removal). Events of interest for this protocol include, but are not limited to, peritonitis, exit site or tunnel infection, and peritoneal dialysis (PD) catheter dysfunction (including PD catheter-related bleeding and PD catheter-related drainage issues).
Time frame: 12-months
Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.
Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events.
Time frame: 12-months
Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing
Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing
Time frame: 12-months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.