Dialysis; Complications, End Stage Renal Disease, Volume Overload
Conditions
Keywords
Sensor, Volume Overload, Dialysis, Bioimpedance
Brief summary
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.
Detailed description
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data. The Sixty device uses diffuse reflectance spectroscopy to measure fluid status. 20 patients will be assessed during the study observation period. 10 patients undergo an observation period of approximately three weeks. The patients will be asked to wear the Sixty device during dialysis and at night throughout the study observation period. Following the completion of this 3 week observation period, an additional 10 patients will wear the Sixty device as per the protocol for 3 weeks. Haemodialysis parameters will be assessed as usual during the study. Bioimpedance measurements will be taken pre and post-dialysis once weekly during the mid-week dialysis session: Patient-reported symptoms related to haemodialysis will be recorded, including symptoms of hypervolaemia and hypovolaemia.
Interventions
DEVICESixty device
Prototype wearable hydration monitor to be worn by patient during dialysis and at night
Sponsors
Beaumont Hospital
patientMpower Ltd.
Design to Value Ltd
Enterprise Ireland
Royal College of Surgeons, Ireland
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* On haemodialysis in an ambulatory care setting. * Demonstrates understanding of correct use of the Sixty device. * Capable and willing to measure blood pressure at home on a daily basis. * Willing to give written informed consent.
Exclusion criteria
* Conditions precluding use of bioimpedance (e.g. Implantable Cardioverter Defibrillator, pacemakers, hearing aids, pregnancy). * Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sixty device versus bioimpedance | 3 weeks | The primary endpoint will be to evaluate the accuracy of the Sixty device data in assessing volume in haemodialysis patients compared to bioimpedance Bioimpedance measurements will be performed using the Fresenius Body Composition Monitor (BCM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of changes in volume status as determined by Sixty device versus blood pressure | 3 weeks | Blood pressure (mmHg) |
| Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session | 3 weeks | Fluid removed (mls/ unit of time) |
| Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis | 3 weeks | Weight (kg) |
| Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring | 3 weeks | Blood volume monitoring: Relative blood volume (%) |
| Acceptability of Sixty device | 3 weeks | The patient's opinion of the acceptability of the Sixty device as assessed by their response to a questionnaire. |
Countries
Ireland
Outcome results
None listed