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

End Stage Renal Disease Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285436
• Other study ID #: CC-P-002
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: CloudCath
• Contact: Brian Fisher
• Phone: +1 (415) 651-3393
• Email: brian[@]cloudcath.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Peritoneal Dialysis-associated Peritonitis
• Peritonitis

Intervention

Device:
• CloudCath System
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.

Locations

Country	Name	City	State
United States	Dialysis Center of Western Massachusetts Llc	Chicopee	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CloudCath

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to peritonitis diagnosis	The time between detection by the CloudCath System and laboratory confirmation of peritonitis.	12-months
Secondary	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	12-months
Secondary	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).	12-months
Secondary	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.	12-months
Secondary	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	12-months