NCT05300191
Suspended
Not Applicable
In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peritoneal Dialysis-associated Peritonitis
- Sponsor
- CloudCath
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Conductivity measurements of effluent dialysate solutions.
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Conductivity measurements of effluent dialysate solutions.
Time Frame: 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
Time Frame: 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.
Study Sites (1)
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