Fluid Status of Dialysis Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-19

Study Completion Date

2025-06-09

Brief Summary

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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.

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Detailed Description

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Conditions

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ESRD (End Stage Renal Disease)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No