Observational Study of BIS in Hemodialysis Patients

Active, not recruiting

• Conditions: Renal Failure Chronic; Kidney Failure, Chronic; Hemodialysis
• Interventions: Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device

• Registration Number: NCT05381961
• Lead Sponsor: ImpediMed Limited

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.

Study Timeline

• Study Start: 2022-04-04
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Primary Completion: 2022-11-08
• Status Verified: 2023-09
• Study Completion: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unstable hemodialysis regimen	Bioimpedance spectroscopy (BIS) measurement, SOZO device	Up to 20 patients who have been on hemodialysis \<6 months, or have unintended weight loss/gain, or have recently been hospitalized
Stable hemodialysis regimen	Bioimpedance spectroscopy (BIS) measurement, SOZO device	Up to 50 patients on hemodialysis \>6 months, with stable target/dry weight, and have not been hospitalized recently

Primary Outcome Measures

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

Trial Locations

Locations (2)

Balboa Research - Rancho Bernardo; 🇺🇸 San Diego, California, United States

Balboa Research - Kearny Mesa; 🇺🇸 San Diego, California, United States