Status:
SUSPENDED
In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
Lead Sponsor:
CloudCath
Conditions:
Peritoneal Dialysis-associated Peritonitis
End Stage Renal Disease
Eligibility:
All Genders
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05300191
Start Date
September 15 2018
End Date
December 31 2024
Last Update
September 21 2023
Active Locations (1)
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1
CloudCath Investigational Site
Guadalajara, Jalisco, Mexico