Assessment of a Wearable Ultrafiltration Device

NCT06832696 | Not Yet Recruiting

• 1 other identifier: 15436
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney failure is common. In some people the ability of the kidneys to clean poisons out of the blood gets so low they need to be hooked up to a machine three times a week to do it for them. This is called dialysis. Unfortunately, although this treatment removes those waste products, people who need dialysis die much more often than people who don't need dialysis. Dialysis causes extreme stress on the body and leads to many organs being damaged. Removing fluid from the body quickly causes the equivalent of repeated little heart attacks or little strokes in the brain. Many patients struggle to tolerate having all the fluid that they have drunk since their last dialysis session removed- without unpleasant symptoms of dangerously low blood pressure (which makes the damage worse). Dialysis treatments can be done more slowly or more often, but that means having to spend a lot more time at the hospital and is difficult for the health system to be able to provide the extra treatment time. Could extra fluid be removed in between dialysis sessions? Up to now there has not been a way to effectively do this. Investigators have now designed and built an entirely new, very small and very simplified, device that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for conventional dialysis sessions, but it can provide additional and gentle removal of fluid which wasn't able to be taken off during a standard treatment session. If this study is successful, it will be the first time that a wearable device has been successfully built and used to take off extra fluid when dialysis patients are not in the hospital. The ability to do this opens up the possibility of, 1) helping to treat patients (both making people feel better and live longer) who can't tolerate getting off all the fluid in the short 3-4 hours they are on the dialysis machine in the hospital, and 2) helping patients who feel OK having the fluid taken off but are silently being subjected to damage to their organs due to the rapid removal, have reduced damage.

Conditions

Hemodialysis; Ultrafiltration

Keywords

Hemodialysis; Ultrafiltration

Outcome Measures

Primary Outcomes (3)

• The device is operational

  The device turns on and is able to pump blood through the extracorporeal circuit

  From enrollment to end of treatment at 4 weeks.

• The device runs for the desired duration

  Achieved by a pre-determined amount of fluid to be removed. If the device runs for the desired length of time to achieve the desired amount of ultrafiltration (eg. 500ml at 2ml/min = 4.2hrs)

  From enrollment to end of treatment at 4 weeks.

• The device is comfortable to wear

  Comfort will be 'measured' by asking for patient input and feedback

  From enrollment to end of treatment at 4 weeks.

Secondary Outcomes (3)

• Reduction in Hemodialysis induced acute myocardial injury

  From enrolment until the end of treatment at 4 weeks.

• Reduction in Intradialytic Weight Gain

  From enrollment to end of study treatment at 4 weeks.

• Reduction in Ultrafiltration Requirements during HD

  From enrollment to end of treatment at 4 weeks.

Other Outcomes (5)

• Change in pre-hemodialysis volume status

  From enrollment to end of treatment at 4 weeks.

• Improvement in patient subjective state

  From enrollment to end of treatment at 4 weeks.

• Changes in hemodynamic response in hemodialysis

  From enrollment to end of treatment at 4 weeks.

Study Arms (1)

Patients receiving hemodialysis that struggle with fluid removal during dialysis

EXPERIMENTAL

In patients receiving hemodialysis treatment, high amounts of fluid removed in a short time (3-4 hours) can lead to unpleasant symptoms, low blood pressure and can cause bodily stress and organ damage. Leaving this extra fluid in the body also causes undue bodily stress. Investigators need to find gentler, more tolerable ways to remove fluid from patients that need hemodialysis. Our investigators have designed and built a new, very small and very simplified device (RUF-D) that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for dialysis treatments, but it can provide additional and gentle removal of fluid between dialysis treatments which wasn't able to be taken off during a standard treatment session.

Device: RUF-D

Interventions

RUF-D DEVICE

We have developed a simplified fluid removal device (RUF-D) to address the challenges that patients face with being unable to remove the fluid they need with standard dialysis. Participants 01-09 will receive one week of baseline observation (three HD treatments) with two weeks of supervised intervention using RUF-D post HD on Mondays and Wednesdays for up to six hours (total three-week study). Participants 10-18 will receive one week of baseline observation, two weeks of intervention (identical to cohort one above), with an additional week of intervention (total four weeks) where participants will be fitted with the RUF-D (ensuring functionality) before going home with the device in operation for up to six hours twice weekly.

Patients receiving hemodialysis that struggle with fluid removal during dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one of the following:
• Average per-session IDWG ≥ 4.0% of dry weight in the last month
• Inability to consistently achieve dry weight with current HD
• Need for additional HD treatments to achieve prescribed dry weight
• HD sessions three times/week
• Age ≥ 18 years
• Dialyzing via central venous access
• Willing and able to provide informed consent

You may not qualify if:

• Active infections
• Non-compliance to hemodialysis prescription/schedule

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Study Officials

• Dr. Christopher McIntyre, MBBS DM

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarrin Penny, RN, PhD, CNeph (C)

CONTACT

519-685-8500; jarrin.penny@lhsc.on.ca

Kathy Koyle

CONTACT

519-685-8500; kathleen.koyle@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Medical Biophysics and Paediatrics,

Model Details: The proposed study is essentially a feasibility study of both a novel device and therapeutic approach to volume management. Although significant improvement in volume status would be highly impactful, this study will still be deemed a success if initial experience supports that the use of the device is feasible and useable. Efficacy measures relating to the removal of fluid have been chosen to provide objective measures and allow the development of a rational sample size calculation. Investigators aim to study 18 dialysis patients in a prospective unblinded fashion with all recruited participants utilizing the intervention - allowing comparison of primary and secondary end points from baseline assessment and comparison after successful utilization of RUF-D.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 18, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Not yet determined
• Access Criteria: Not yet determined

Locations

CA (1)