Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System (NCT03072732) | Clinical Trial Compass
CompletedNot Applicable
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
United States40 participantsStarted 2016-11-03
Plain-language summary
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device. The µ-Cor System will record the fluid changes in the body, as well as ECG (electrocardiogram or an electrical tracing of your heart rhythm) heart rate, breathing rate, posture and activity at regular intervals.
The information collected by the µ-Cor System will then be compared to the actual fluid removed through dialysis and to the information collected by an FDA (Food and Drug Administration) cleared device called ZOE (NonInvasive Medical Technologies), a monitor which also measures the fluid changes in the body.
The objectives of this study are to document any differences in measurement of thoracic impedance obtained from the µ-Cor System and the ZOE system. Thoracic impedance is a measure of the electrical activity in the chest that varies with changes in body size and composition, fluid volume, breathing status and other variables.
Measurements of the amount of fluid removed during dialysis will also be compared between the µ-Cor System, the ZOE system and the actual fluid removed.
The ability of the µ-Cor System to measure thoracic impedance will be tested by placing the device randomly at one of two locations:
* Study Arm 1: side location- below left axilla
* Study Arm 2: front location - upper left pectoral area
Both the µ-Cor System and the ZOE System will be worn simultaneously during one dialysis session. The ZOE system device is placed on the chest- 2 points: 1 at the base of your neck and 1 in your mid chest.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women at least 21 years of age.
* Is currently scheduled to undergo hemodialysis 3 times per week in a clinic setting and has been on this regimen for at least 3 months.
* For those patients with CHF: were diagnosed with CHF by a qualified provider and show symptomatic signs of New York Heart Association (NYHA) Class II to IV at enrollment.
* Is prescribed a net fluid removal of at least 2.5 L during the hemodialysis session.
* Is willing and able to sign informed consent in English.
Exclusion Criteria:
* Is a female patient with a known pregnancy or is unsure of pregnancy status.
* Has known allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
* Has skin breakdown in areas where device and electrode placement is required.
* Was hospitalized within the 2 weeks prior to enrollment.
* Had intradialytic hypotension requiring administration of intravenous (IV) fluids of ≥250 mL or that resulted in a referral to urgent care, within 2 weeks prior to enrollment.
* Had myocardial infarction, acute coronary syndrome, or stroke within 4 weeks prior to enrollment.
* Has active nephrotic syndrome
* Has severe malnutrition, as diagnosed per a qualified provider.
* Is participating in another clinical trial.
* Has an implanted device that might interfere with the µ-Cor.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Correlation of Thoracic Impedance With Ultra-filtration Volume (UFV) Between uCor and ZOE
Timeframe: 15 minutes prior the start of one hemodialysis session to 15 minutes post completion of one hemodialysis session, approximately 2 to 6 hours.