Status:
UNKNOWN
Observational Study of BIS in Hemodialysis Patients
Lead Sponsor:
ImpediMed Limited
Collaborating Sponsors:
California Institute of Renal Research
Frenova Renal Research
Conditions:
Kidney Failure, Chronic
Renal Failure Chronic
Eligibility:
All Genders
18+ years
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 patie...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- 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);
- Patient determined by the attending physician unlikely to be compliant with study procedures.
Key Trial Info
Start Date :
April 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05381961
Start Date
April 4 2022
End Date
September 1 2023
Last Update
September 28 2023
Active Locations (2)
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1
Balboa Research - Kearny Mesa
San Diego, California, United States, 92111
2
Balboa Research - Rancho Bernardo
San Diego, California, United States, 92127