NCT04623281

Haemodialysis Outcomes & Patient Empowerment Study 02

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• End Stage Renal Disease
• Dialysis; Complications
• Volume Overload

Interventions

Type	Name	Description
DEVICE	Sixty device	Prototype wearable hydration monitor to be worn by patient during dialysis and at night

Timeline

• Start date: 2021-01-21
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2020-11-10
• Last updated: 2021-09-05

Locations

1 site across 1 country: Ireland