Fluid Status of Dialysis Subjects

HemoCept Inc.12 enrolled

Overview

The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data during dialysis and HemoCept device data.

Study Type

OBSERVATIONAL

Enrollment

Conditions

ESRD (End Stage Renal Disease)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Study 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 willing and able 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 Exclusion Criteria: * 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.

Locations (1)

Sierra Nevad Specialty Care

Reno, Nevada, United States

Outcomes

Primary Outcomes

Correlation between HemoCept device and changes in dry weight.

The primary end point will be to determine if there is a correlation between HemoCept device data and dry weight changes during dialysis. The primary analysis will be conducted at specific points during dialysis treatment: prior to dialysis, in the middle of the dialysis session, and immediately following the completion of dialysis treatment.

Time frame: At specified points during dialysis treatment for 9 dialysis sessions, over the course of 3 weeks.

Secondary Outcomes

Device-related adverse events: device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure

All secondary endpoints will be summarized descriptively, and no hypothesis tests are planned.

Time frame: From enrollment until the completion of 9 dialysis sessions, over a period of 3 weeks.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.