Observational Study of BIS in Hemodialysis Patients

NCT ID: NCT05381961

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2023-09-30

Brief Summary

This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.

Detailed Description

This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.

Conditions

Kidney Failure, Chronic; Renal Failure Chronic; Hemodialysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stable hemodialysis regimen

Up to 50 patients on hemodialysis \>6 months, with stable target/dry weight, and have not been hospitalized recently

Bioimpedance spectroscopy (BIS) measurement, SOZO device

Intervention Type: DEVICE

All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.

Unstable hemodialysis regimen

Up to 20 patients who have been on hemodialysis \<6 months, or have unintended weight loss/gain, or have recently been hospitalized

Bioimpedance spectroscopy (BIS) measurement, SOZO device

Intervention Type: DEVICE

All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.

Interventions

Bioimpedance spectroscopy (BIS) measurement, SOZO device

All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age >=18 years of age;

2. End-stage renal disease with a GFR <15 mL/min/1.73m^2 and dialysis dependent requiring 3-times weekly dialysis;

3. Able and willing to remove shoes and stand on SOZO for BIS measurements;

4. Able to provide written informed consent and authorization to use and disclose health information.

Exclusion Criteria

1. Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion;

2. Has a clinical condition that would not allow them to complete the study;

3. Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception;

4. Is lactating;

5. Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator);

6. Has an amputation of a limb/s resulting in them being unable to make contact with the SOZO electrodes (amputations of fingers and toes are not an exclusion);

7. Patient determined by the attending physician unlikely to be compliant with study procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Institute of Renal Research

OTHER

Sponsor Role: collaborator

Frenova Renal Research

OTHER

Sponsor Role: collaborator

ImpediMed Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Boiskin, MD

Role: PRINCIPAL_INVESTIGATOR

Balboa Research

Locations

Balboa Research - Kearny Mesa

San Diego, California, United States

Balboa Research - Rancho Bernardo

San Diego, California, United States

Countries

United States

Other Identifiers

IPD-ESRD-001

Identifier Type: -

Identifier Source: org_study_id