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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05300191
• Other study ID #: CC-L-003
• Status: Suspended
• Start date: September 15, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: CloudCath
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Peritoneal Dialysis-associated Peritonitis
• Peritonitis

Intervention

Diagnostic Test:
• Effluent dialysate
Effluent dialysate samples evaluated for evidence of peritonitis

Locations

Country	Name	City	State
Mexico	CloudCath Investigational Site	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
CloudCath

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately post dialysis
Primary	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.	immediately post dialysis