Fluid Status of ESRD Patients Undergoing Dialysis

NCT07217470 | Completed

• 1 other identifier: PRT-017
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The pilot clinical study will assess the correlation between fluid removal during dialysis and HemoCept device data.

Conditions

ESRD (End Stage Renal Disease)

Outcome Measures

Primary Outcomes (1)

• Correlation between dry weight changes and HemoCept device measurements.

  The primary analysis will be conducted using HemoCept device readings taken before dialysis and at the end of dialysis, just prior to return of blood and fluid from the machine. The device data will then be assessed for its comparison to dry weight changes.

  Before and after one dialysis session, over the course of 1 day

Secondary Outcomes (1)

• Device related adverse events, and the possible correlation of skin tone to device results.

  Before and after 1 dialysis session, over the course of 1 day.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects between (and including) the ages of 18 and 75 and who meet all the Inclusion/Exclusion criteria

You may qualify if:

• Subject or representatives must have voluntarily signed the informed consent form before any study related procedures
• Subjects can be any gender, but must be between (and including) 18 and 75 years of age
• Subject has been on dialysis for more than 90 days and has been diagnosed with end stage kidney disease
• Subject is able and willing to provide informed consent and HIPAA authorization.
• Subject is able and willing to meet all study requirements
• Subject is able to place electrodes on bilateral deltoids and above the pant line on the waist.

You may not qualify if:

• Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
• Subject has a personal medical history that includes: Long Q-T syndrome, Cardiac channelopathies, genetic heart defects, Seizures, Acute untreated blood clotting disorders or acute untreated bleeding disorders
• Subject has had a heart transplant.

Sponsors & Collaborators

• HemoCept Inc.: lead

Study Sites (1)

Sierra Nevad Specialty Care

Reno, Nevada, 89511, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jusmin Patel, MD

  Sierra Nevada Specialty Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 16, 2025
• Study Start: August 18, 2025
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)