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
• Interventions: Diagnostic Test: Effluent dialysate

• 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

Arm && Interventions

Group	Intervention	Description
Peritoneal dialysis patients	Effluent dialysate	Patients undergoing peritoneal dialysis. Patients may be using either Continuous Ambulatory Peritoneal Dialysis (CAPD), Continuous Cycling Peritoneal Dialysis (CCPD) or Intermittent Peritoneal Dialysis (IPD).

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