Observational Study of BIS in Hemodialysis Patients

NCT05381961 | Unknown FDA Device

• 1 other identifier: IPD-ESRD-001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Kidney Failure, Chronic; Renal Failure Chronic; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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

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

Interventions

Bioimpedance spectroscopy (BIS) measurement, SOZO device 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.

Stable hemodialysis regimen; Unstable hemodialysis regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \>=18 years of age;
• End-stage renal disease with a GFR \<15 mL/min/1.73m\^2 and dialysis dependent requiring 3-times weekly dialysis;
• Able and willing to remove shoes and stand on SOZO for BIS measurements;
• Able to provide written informed consent and authorization to use and disclose health information.

You may not qualify if:

• Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion;
• Has a clinical condition that would not allow them to complete the study;
• Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception;
• Is lactating;
• Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator);
• Patient determined by the attending physician unlikely to be compliant with study procedures.

Sponsors & Collaborators

• ImpediMed Limited: lead
• California Institute of Renal Research: collaborator
• Frenova Renal Research: collaborator

Study Sites (2)

Balboa Research - Kearny Mesa

San Diego, California, 92111, United States

Location

Balboa Research - Rancho Bernardo

San Diego, California, 92127, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Mark Boiskin, MD

  Balboa Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 19, 2022
• Study Start: April 4, 2022
• Primary Completion: November 8, 2022
• Study Completion: September 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)