Fluid Status of Dialysis Subjects

HemoCept Inc.

Status: Completed

Conditions: ESRD (End Stage Renal Disease)

Study type: Observational

Funder types: Industry

Identifiers

NCT07217041

PRT-010

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.