Haemodialysis Outcomes & Patient Empowerment Study 02

Study Overview
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Brief Summary
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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
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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.

Official Title
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Haemodialysis Outcomes & Patient Empowerment Study 02

Conditions
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End Stage Renal Disease, Dialysis; Complications, Volume Overload

Intervention / Treatment
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* Device: Sixty device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational group<br>Observational group of 10 haemodialysis patients following usual care for 3 weeks. | Device: Sixty device<br>* Prototype wearable hydration monitor to be worn by patient during dialysis and at night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sixty device versus bioimpedance | 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) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session | Fluid removed (mls/ unit of time) | 3 weeks | 
| Comparison of changes in volume status as determined by Sixty device versus blood pressure | Blood pressure (mmHg) | 3 weeks | 
| Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis | Weight (kg) | 3 weeks | 
| Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring | Blood volume monitoring: Relative blood volume (%) | 3 weeks | 
| Acceptability of Sixty device | The patient's opinion of the acceptability of the Sixty device as assessed by their response to a questionnaire. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensor, Volume Overload, Dialysis, Bioimpedance