Observational Study of BIS in Hemodialysis Patients

Observational Study of Bioimpedance Spectroscopy (BIS) for Use in a Renal Population

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hemodialysis; Kidney Failure, Chronic; Renal Failure Chronic
• Intervention / Treatment: Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92111
      • Balboa Research - Kearny Mesa
    • San Diego, California, United States, 92127
      • Balboa Research - Rancho Bernardo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (aged 18+ years) with end-stage renal disease, are known to a study investigator, and undergo hemodialysis 3-times per week at an outpatient dialysis unit.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stable hemodialysis regimen; Up to 50 patients on hemodialysis >6 months, with stable target/dry weight, and have not been hospitalized recently	Device: 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.
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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS correlation with amount of fluid dialyzed	BIS-measured fluid change (volume) will be analyzed for correlation with the volume of fluid removed during hemodialysis as documented on dialysis treatment records.	12 hemodialysis sessions (over 4 to 6 weeks)

Collaborators and Investigators

• Sponsor: ImpediMed Limited
• Collaborators: California Institute of Renal Research; Frenova Renal Research
• Investigators: Principal Investigator: Mark Boiskin, MD, Balboa Research

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): November 8, 2022
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: IPD-ESRD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes