End Stage Renal Disease
Conditions
Brief summary
The purpose of this study is to investigate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status monitor in hemodialysis patients. The study will measure the changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. Subcutaneous impedance trends will also be evaluated between dialysis sessions.
Interventions
Insertable cardiac monitor
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who currently undergo in-clinic hemodialysis treatment prescribed 2 or 3 times per week * Patients willing to be implanted with the Reveal LINQ™ device * Patients greater than 21 years of age * Patients willing and able to comply with the study procedures including giving informed consent
Exclusion criteria
* Patient has an active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc) * Patients who currently undergo home dialysis treatment * Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager. * Patient with a recent infection defined as 1) bacteremia within 60 days OR 2) (nonbacteremic) infection within 14 days * Patient not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin, or major medical or social conditions expected to reduce survival to \< 6 months), in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Fluid Volume Removed | 24 Days | The average fluid volume removal during the dialysis session over all patients. |
| Change in Subcutaneous Impedance | 24 days | The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic 'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions.
Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Diagnostic |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 53.3 years STANDARD_DEVIATION 19 |
| Region of Enrollment Australia | 7 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 7 |
| serious Total, serious adverse events | 1 / 7 |
Outcome results
Primary
Average Fluid Volume Removed
The average fluid volume removal during the dialysis session over all patients.
Time frame: 24 Days
Population: Enrolled patients implanted with a LINQ device that had at least one dialysis session between 7 and 30 days post-implant. Formal statistical analysis was not performed because the likelihood from the pre-specified model did not converge due to small sample size. Average fluid loss is summarized instead.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic | Average Fluid Volume Removed | 2948 mL | Standard Deviation 683 |
Primary
Change in Subcutaneous Impedance
The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions
Time frame: 24 days
Population: Patients implanted with a LINQ having at least one dialysis session between 7 and 30 days post-implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic | Change in Subcutaneous Impedance | 207 ohm | Standard Deviation 97 |