Observational Study of BIS in Hemodialysis Patients

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05381961
• Other study ID #: IPD-ESRD-001
• Status: Active, not recruiting
• Start date: April 4, 2022
• Est. completion date: September 2023

Study information

• Verified date: September 2023
• Source: ImpediMed Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 2023
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis
• Kidney Failure, Chronic
• Renal Failure Chronic
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Balboa Research - Kearny Mesa	San Diego	California
United States	Balboa Research - Rancho Bernardo	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
ImpediMed Limited	California Institute of Renal Research, Frenova Renal Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)