Observational Study of BIS in Hemodialysis Patients
Status unconfirmed
Conditions studied: Kidney Failure, Chronic, Renal Failure Chronic, Hemodialysis
In brief
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.
Key facts
- Study ID
- NCT05381961
- Run by
- ImpediMed Limited
- People needed
- 70
- Starts
- 2022-04-04
- Expected to finish
- 2023-09-01
- Last updated by the study team
- 2023-09-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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);
- 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.
Where it is running
- Balboa Research - Kearny Mesa — San Diego, California, United States
- Balboa Research - Rancho Bernardo — San Diego, California, United States
Full record on ClinicalTrials.gov
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