Haemodialysis Outcomes & Patient Empowerment Study 02 (HOPE-02)

Royal College of Surgeons, Ireland

Status

Completed

Conditions

End Stage Renal Disease

Volume Overload

Dialysis; Complications

Treatments

Device: Sixty device

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04623281

HOPE-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.