Fluid Status of ESRD Patients Undergoing Dialysis

N/ACompletedNCT07217470

HemoCept Inc.26 enrolled

Overview

The pilot clinical study will assess the correlation between fluid removal 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: * 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. 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 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.

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

Secondary Outcomes

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

-Device-related adverse events: device-related adverse events included all adverse eventsclassified as definitely, probably, possibly, or undetermined relation to the device or procedure --Exploratory correlation of skin tone and device performance: Monk Skin Tone data will be collected to explore potential correlation between subject skin tone and HemoCept device readings.

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

Data from ClinicalTrials.gov

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