In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device

Suspended

• Conditions: Peritoneal Dialysis-associated Peritonitis; End Stage Renal Disease

• Registration Number: NCT05300191
• Lead Sponsor: CloudCath

Brief Summary

A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-15
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-16
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Males or females with end-stage renal disease on peritoneal dialysis for a minimum of 10 days prior to obtaining the specimen.
• Specimens shall be leftover (or remnant) from a specimen that has been drained as part of the routine care for the patient.
• Specimens shall not contain any individually identifiable information from the patient it was obtained from.

Exclusion Criteria

• Patients providing specimens should not be under the administration of any antibiotics other than those utilized for the treatment of peritonitis.
• Patients providing specimens should not suffer from a known liver disease or from ovarian or liver cancer.
• Patients providing specimens should not be under the administration of calcium channel blockers or amlodipine for less than 30 days prior to providing a specimen.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conductivity measurements of effluent dialysate solutions.	immediately post dialysis	a quantitative assessment of conductivity of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score.
Spectral measurements of effluent dialysate solutions	immediately post dialysis	a quantitative analysis of the spectral characteristics of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score.

Trial Locations

Locations (1)

CloudCath Investigational Site; 🇲🇽 Guadalajara, Jalisco, Mexico