A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease; Peritonitis; Peritoneal Dialysis-associated Peritonitis
• Interventions: Device: CloudCath System

• Registration Number: NCT05285436
• Lead Sponsor: CloudCath

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study Start: 2022-03-16
• Study First Posted: 2022-03-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-16
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

• currently using peritoneal dialysis
• provides informed consent
• willing to comply with the requirements of the study
• has cellular data coverage at home

Key

Exclusion Criteria

• active or history of cancer requiring chemotherapy within prior 6 months
• signs or symptoms of an active infection within 14 days prior to enrollment
• peritonitis diagnosis within 30 days prior to enrollment
• participating in another investigational device or drug study that may potentially affect study results
• other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CloudCath detection	CloudCath System	Active monitoring of dialysate effluent by the CloudCath System.

Primary Outcome Measures

Name	Time	Method
Time to peritonitis diagnosis	12-months	The time between detection by the CloudCath System and laboratory confirmation of peritonitis.

Secondary Outcome Measures

Name	Time	Method
Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.	12-months	Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events.
Agreement in peritonitis detection between the CloudCath System and clinical criteria.	12-months	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
Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis	12-months	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).
Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing	12-months	Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing

Trial Locations

Locations (1)

Dialysis Center of Western Massachusetts Llc; 🇺🇸 Chicopee, Massachusetts, United States