Haemodialysis Outcomes & Patient Empowerment Study 02
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dialysis; Complications
- End Stage Renal Disease
- Volume Overload
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04623281
- Collaborators
- Beaumont Hospital
- patientMpower Ltd.
- Design to Value Ltd
- Enterprise Ireland
- Investigators
- Principal Investigator: Renal Dialysis Centre, Beaumont Hospital RCSI