Haemodialysis Outcomes & Patient Empowerment Study 02

NCT04623281 | Completed

• 1 other identifier: HOPE-02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Dialysis; Complications; Volume Overload

Keywords

Sensor; Volume Overload; Dialysis; Bioimpedance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session

  3 weeks

• Comparison of changes in volume status as determined by Sixty device versus blood pressure

  3 weeks

• Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis

  3 weeks

• Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring

  3 weeks

• Acceptability of Sixty device

  3 weeks

Study Arms (1)

Observational group

Observational group of 10 haemodialysis patients following usual care for 3 weeks.

Device: Sixty device

Interventions

Sixty device DEVICE

Prototype wearable hydration monitor to be worn by patient during dialysis and at night

Observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Beaumont Hospital: collaborator
• patientMpower Ltd.: collaborator
• Design to Value Ltd: collaborator
• Enterprise Ireland: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, Leinster, 9, Ireland

Location

Related Publications (1)

• 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.

  PMID: 35073985 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Renal Dialysis Centre, Beaumont Hospital

  RCSI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 10, 2020
• Study Start: January 21, 2021
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 5, 2021

Record last verified: 2020-10

Locations

IE (1)