Peritoneal Dialysis-associated PeritonitisNCT05300191
In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
An observational study of Peritoneal Dialysis-associated Peritonitis and End Stage Renal Disease, run by CloudCath at 1 site in Mexico.
Trial summary
A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Dialysis-associated Peritonitis, End Stage Renal Disease
- What is being tested?
- Effluent dialysate
- How many people
- 500 participants
- Where
- 1 siteMexico
- Study dates
- 15 Sep 2018to 31 Dec 2024
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients currently using peritoneal dialysis and at elevated risk for developing peritonitis.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.
- Being tested
- Effluent dialysate
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effluent dialysateDiagnostic test
Effluent dialysate samples evaluated for evidence of peritonitis
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Effluent dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: immediately post dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Sep 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: temporary pause due to business priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis-associated PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- CloudCath
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Briggs, MD, PhD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300191
- Sponsor's protocol ID
- CC-L-003
- Status last verified
- Sep 2023
- First submitted
- 9 Mar 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
- ClinicalTrials.gov ID
- NCT05300191
- Acronym / sponsor ID
- CC-L-003
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: temporary pause due to business priorities
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- CloudCathIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis patients | – | Diagnostic Test: Effluent dialysatePatients undergoing peritoneal dialysis. Patients may be using either Continuous Ambulatory Peritoneal Dialysis (CAPD), Continuous Cycling Peritoneal Dialysis (CCPD) or Intermittent Peritoneal Dialysis (IPD). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients currently using peritoneal dialysis and at elevated risk for developing peritonitis.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effluent dialysateEffluent dialysate samples evaluated for evidence of peritonitis | Diagnostic test | Peritoneal dialysis patients |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Related trials for Peritoneal Dialysis-associated Peritonitis
RecruitingObservational study
Peritoneal Dialysis Registration System (PERSIST)
ESRD, Disorders Associated With Peritoneal Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Briggs, MD, PhD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis-associated Peritonitis and End Stage Renal Disease, run by CloudCath at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectral measurements of effluent dialysate solutions (time frame: immediately post dialysis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.