Heart FailureNCT02140905
Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
An observational study of Heart Failure and Kidney Disease, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated with the amount of fluid removed during dialysis (ΔF) for subjects with ESRD and possibly… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Heart Failure, Kidney Disease
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be volunteers, solicited using accepted recruitment methods, such as through clinicians associated with dialysis centers. Subjects will have a clinical diagnosis of Kidney Failure and will be currently undergoing Hemodialysis with possible related co-morbidity of Heart Failure.
Who may be able to join
- Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
- Subject will have one or more of the following clinical diagnoses related to fluid-management issues: ESRD, Heart Failure.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
Who cannot join
- Subject is participating in another clinical study that may affect the results of either study.
- Subject is unable or not willing to wear electrode patches as required.
- Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- Subject is considered by the PI to be medically unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Dialysis Center, Inc.
North Brunswick, New Jersey, 08902
About this study
Official title: Validation of Neck-Worn Monitoring System - A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements During Hemodialysis
The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated with the amount of fluid removed during dialysis (ΔF) for subjects with ESRD and possibly Heart Failure.
The second objective is to demonstrate correlation between ΔSFI and relative changes in impedance (ΔZ) as measured by the reference device.
Read the detailed description
The investigators propose a study for validating the test device's measurement of a parameter called 'sternal fluid index' (SFI) in patients with diagnosed medical conditions related to fluid management, e.g. end-stage renal disease (ESRD), that are undergoing dialysis. The reference device for the study measures the averaged amplitude of a thoracic bio-impedance signal (Z) and a parameter called 'thoracic fluid content' (TFC), which is equal to 1000/Z. The test device measures SFI from a localized region near the sternum, whereas the reference device measures Z and TFC from the entire thoracic cavity. This means Z (or TFC) and SFI, if measured at approximately the same time, will likely correlate but have different absolute values. Thus, the statistical analysis will investigate the ability of SFI to track fluids, as well as the agreement between fluid-dependent trends displayed by SFI and Z (or TFC), as described below.
During the study the investigators will collect multiple samples, each containing a value of SFI from the test device, and values of TFC and Z from the reference device. The investigators will enroll approximately 20-50 subjects, with the goal of at least 20 subjects completing the study. The statistical analysis will include data from all subjects that complete the study. All subjects will undergo dialysis in a clinic. Approximately half to a third will have both ESRD and Heart Failure (HF). The investigators will measure a sample from each subject every 15 minutes during a standard dialysis session, which typically lasts about 3 to 4 hours. Levels of extracted fluids, determined by the dialysis machine, will be recorded at the time each sample is measured.
The statistical model compares time-dependent changes in SFI and Z values collected during dialysis. It is designed is to demonstrate: 1) that the test device is effective in characterizing fluid levels when used as intended; and 2) that the test and reference devices' measurements of trends in fluids are substantially equivalent, since they sense different physiological regions which are expected to yield different values of impedance.
- Conditions
- Heart Failure, Kidney Disease
- Keywords
- Hemodialysis, Heart failure, Impedance, Fluids
- Medical subject headings
- Heart Failure, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing hemodialysis. | Subjects participating in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of fluid measurement made with the Neck-Worn Monitoring System and those with an FDA approved fluid measurement device. Both measurements will be compared to the actual fluids removed during one dialysis session.
The study's primary objective is to determine the effectiveness of SFI measurements made by the Neck-Worn Monitoring System for characterizing fluid levels compared to an FDA approved device.
Data collected includes SFI from the Neck-Worn Monitoring System and a reference device, fluid extracted during a dialysis session. Data will be collected every 15 minutes.
Measured: Measurements will be collected during one dialysis session. Each Session will last between 2 and 5.5 hours. All measurements will be completed within one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Banet, PhD, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140905
- Sponsor's protocol ID
- PERM-IRB-0001
- Status last verified
- May 2014
- First submitted
- 30 Apr 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Neck-Worn Monitoring System - A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements During Hemodialysis
- ClinicalTrials.gov ID
- NCT02140905
- Acronym / sponsor ID
- PERM-IRB-0001
- Conditions
- Heart Failure, Kidney Disease
- Keywords
- Hemodialysis, Heart failure, Impedance, Fluids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated with the amount of fluid removed during dialysis (ΔF) for subjects with ESRD and possibly Heart Failure.
The second objective is to demonstrate correlation between ΔSFI and relative changes in impedance (ΔZ) as measured by the reference device.
Detailed description
The investigators propose a study for validating the test device's measurement of a parameter called 'sternal fluid index' (SFI) in patients with diagnosed medical conditions related to fluid management, e.g. end-stage renal disease (ESRD), that are undergoing dialysis. The reference device for the study measures the averaged amplitude of a thoracic bio-impedance signal (Z) and a parameter called 'thoracic fluid content' (TFC), which is equal to 1000/Z. The test device measures SFI from a localized region near the sternum, whereas the reference device measures Z and TFC from the entire thoracic cavity. This means Z (or TFC) and SFI, if measured at approximately the same time, will likely correlate but have different absolute values. Thus, the statistical analysis will investigate the ability of SFI to track fluids, as well as the agreement between fluid-dependent trends displayed by SFI and Z (or TFC), as described below.
During the study the investigators will collect multiple samples, each containing a value of SFI from the test device, and values of TFC and Z from the reference device. The investigators will enroll approximately 20-50 subjects, with the goal of at least 20 subjects completing the study. The statistical analysis will include data from all subjects that complete the study. All subjects will undergo dialysis in a clinic. Approximately half to a third will have both ESRD and Heart Failure (HF). The investigators will measure a sample from each subject every 15 minutes during a standard dialysis session, which typically lasts about 3 to 4 hours. Levels of extracted fluids, determined by the dialysis machine, will be recorded at the time each sample is measured.
The statistical model compares time-dependent changes in SFI and Z values collected during dialysis. It is designed is to demonstrate: 1) that the test device is effective in characterizing fluid levels when used as intended; and 2) that the test and reference devices' measurements of trends in fluids are substantially equivalent, since they sense different physiological regions which are expected to yield different values of impedance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing hemodialysis. | – | –Subjects participating in the study |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be volunteers, solicited using accepted recruitment methods, such as through clinicians associated with dialysis centers. Subjects will have a clinical diagnosis of Kidney Failure and will be currently undergoing Hemodialysis with possible related co-morbidity of Heart Failure.
Key inclusion criteria (4 listed)
- Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
- Subject will have one or more of the following clinical diagnoses related to fluid-management issues: ESRD, Heart Failure.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
Key exclusion criteria (5 listed)
- Subject is participating in another clinical study that may affect the results of either study.
- Subject is unable or not willing to wear electrode patches as required.
- Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- Subject is considered by the PI to be medically unsuitable for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of fluid measurement made with the Neck-Worn Monitoring System and those with an FDA approved fluid measurement device. Both measurements will be compared to the actual fluids removed during one dialysis session.
Time frame: Measurements will be collected during one dialysis session. Each Session will last between 2 and 5.5 hours. All measurements will be completed within one month.
The study's primary objective is to determine the effectiveness of SFI measurements made by the Neck-Worn Monitoring System for characterizing fluid levels compared to an FDA approved device. Data collected includes SFI from the Neck-Worn Monitoring System and a reference device, fluid extracted during a dialysis session. Data will be collected every 15 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Banet, PhD principal investigator
Baxter Healthcare Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Kidney Disease, run by Baxter Healthcare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of fluid measurement made with the Neck-Worn Monitoring System and those with an FDA approved fluid measurement device. Both measurements will be compared to the actual fluids removed during one dialysis session. (time frame: Measurements will be collected during one dialysis session. Each Session will last between 2 and 5.5 hours. All measurements will be completed within one month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.