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

CloudCath

Status: Suspended

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

Treatments: Diagnostic Test: Effluent dialysate

Study type: Observational

Funder types: Industry

Identifiers

NCT05300191

CC-L-003

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Peritoneal dialysis patients

Description:

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

Treatment:

Diagnostic Test: Effluent dialysate