SuspendedNCT05300191Updated Sep 21, 2023

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

An observational study in Peritoneal Dialysis-associated Peritonitis and End Stage Renal Disease, sponsored by CloudCath. Suspended at 1 site in Mexico. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by CloudCath · Observational

Why this study was suspended

temporary pause due to business priorities

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 500
Sex: All

Study 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 studied

Peritoneal Dialysis-associated Peritonitis
End Stage Renal Disease

Browse trials for

Kidney Failure, Chronic 2,108

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's planned enrollment of 500 is above the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.

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Lead sponsor

CloudCath is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 500 participants (estimated)
Target follow-up: 30 Days
Patient registry: Yes

Groups and cohorts

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

Diagnostic testEffluent dialysate
Effluent dialysate samples evaluated for evidence of peritonitis

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: immediately post dialysis

Study locations

1 site

CloudCath Investigational Site
Guadalajara, Jalisco, Mexico

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05300191
Lead sponsor: CloudCath
Responsible party: Sponsor
First posted: Mar 29, 2022
Start date: Sep 15, 2018
Primary completion: Dec 31, 2024 (estimated)
Completion: Dec 31, 2024 (estimated)
Last update: Sep 21, 2023

Study contacts

Ben Briggs, MD, PhD

study director · University of California, San Francisco

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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