Clinical trial NCT04623281: Haemodialysis Outcomes & Patient Empowerment Study 02
Official title: Haemodialysis Outcomes & Patient Empowerment Study 02
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Dialysis; Complications
Volume Overload
Keywords: Sensor
Volume Overload
Dialysis
Bioimpedance
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Beaumont Hospital
name: patientMpower Ltd.
name: Design to Value Ltd
name: Enterprise Ireland
First posted: 2020-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Require maintenance haemodialysis in an ambulatory care setting. Study will be conducted in a single centre in a tertiary hospital. Patients with a range of baseline fluid statuses will be considered for enrollment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of Sixty device versus bioimpedance
timeFrame: 3 weeks
Secondary outcomes:
measure: Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session
timeFrame: 3 weeks
measure: Comparison of changes in volume status as determined by Sixty device versus blood pressure
timeFrame: 3 weeks
measure: Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis
timeFrame: 3 weeks
measure: Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring
timeFrame: 3 weeks
measure: Acceptability of Sixty device
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
state: Leinster
Study officials:
affiliation: RCSI
name: Renal Dialysis Centre, Beaumont Hospital
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandys V, Edwards C, McAleese P, O'Hare E, O'Seaghdha C. Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients. Pilot Feasibility Stud. 2022 Jan 24;8(1):17. doi: 10.1186/s40814-022-00976-7.