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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-15

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Peritoneal Dialysis-associated Peritonitis End Stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Effluent dialysate

Intervention Type DIAGNOSTIC_TEST

Effluent dialysate samples evaluated for evidence of peritonitis

Interventions

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Effluent dialysate

Effluent dialysate samples evaluated for evidence of peritonitis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No