Haemodialysis Outcomes & Patient Empowerment Study 02

Completed

• Conditions: End Stage Renal Disease; Volume Overload; Dialysis; Complications
• Interventions: Device: Sixty device

• Registration Number: NCT04623281
• Lead Sponsor: Royal College of Surgeons, Ireland

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Study Start: 2021-01-21
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	Sixty device	Observational group of 10 haemodialysis patients following usual care for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Accuracy of Sixty device versus bioimpedance	3 weeks	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beaumont Hospital; 🇮🇪 Dublin, Leinster, Ireland