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

NCT05300191 | Suspended

• 1 other identifier: CC-L-003
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis-associated Peritonitis; End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Spectral measurements of effluent dialysate solutions

  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.

  immediately post dialysis

• Conductivity measurements of effluent dialysate solutions.

  a quantitative assessment of conductivity of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score.

  immediately post dialysis

Study Arms (1)

Peritoneal dialysis patients

Patients undergoing peritoneal dialysis. Patients may be using either Continuous Ambulatory Peritoneal Dialysis (CAPD), Continuous Cycling Peritoneal Dialysis (CCPD) or Intermittent Peritoneal Dialysis (IPD).

Diagnostic Test: Effluent dialysate

Interventions

Effluent dialysate DIAGNOSTIC_TEST

Effluent dialysate samples evaluated for evidence of peritonitis

Peritoneal dialysis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients currently using peritoneal dialysis and at elevated risk for developing peritonitis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CloudCath: lead

Study Sites (1)

CloudCath Investigational Site

Guadalajara, Jalisco, Mexico

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Briggs, MD, PhD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 29, 2022
• Study Start: September 15, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ME (1)