Haemodialysis Outcomes & Patient Empowerment Study 02

End Stage Renal Disease Clinical Trial

— HOPE-02  

Official title:

Haemodialysis Outcomes & Patient Empowerment Study 02

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623281
• Other study ID #: HOPE-02
• Status: Completed
• Start date: January 21, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: October 2020
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dialysis; Complications
• End Stage Renal Disease
• Kidney Failure, Chronic
• Volume Overload

Intervention

Device:
• Sixty device
Prototype wearable hydration monitor to be worn by patient during dialysis and at night

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin	Leinster

Sponsors (5)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Beaumont Hospital, Design to Value Ltd, Enterprise Ireland, patientMpower Ltd.

Country where clinical trial is conducted

Ireland, 

Outcome

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