Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis

May 19, 2014 updated by: Baxter Healthcare Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • North Brunswick, New Jersey, United States, 08902
        • Dialysis Center, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients undergoing hemodialysis.
Subjects participating in the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew Banet, PhD, Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PERM-IRB-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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