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.
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
Active infections
Non-compliance to hemodialysis prescription/schedule
Single group
RUF-D
DeviceWe 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.
The device is operational
The device turns on and is able to pump blood through the extracorporeal circuit
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)
The device is comfortable to wear
Comfort will be 'measured' by asking for patient input and feedback
Reduction in Hemodialysis induced acute myocardial injury
Reduction in number of regional wall motion abnormalities during HD associated with additional interdialytic ultrafiltration, using the RUF-D assessed by echo at each study visit pre and peak dialysis. Regional left ventricular functional assessment will be performed using 2D echocardiography with commercially available equipment (Vivid-I, GE Healthcare) and subsequent automatic analysis of speckle tracked strain curves using automated software (Echo-Pac GE healthcare). Significant stunning will be defined as 50% reduction in regional longitudinal strain.
Reduction in Intradialytic Weight Gain
Weight measurements to calculate Intradialytic Weight Gain
Reduction in Ultrafiltration Requirements during HD
Weight measurements between treatments
Change in pre-hemodialysis volume status
Bioimpedance Body Composition Monitor: Bioelectrical impedance analysis (BIA) is based on the principle of detecting resistance to low-level electrical current flows through intracellular and extracellular fluid. Absolute and relative body composition and assessment of total body water (TBW) will be taken using a segmental multifrequency BIA analyzer and Body Composition Monitors (BCM, Fresenius Medical Care, Germany). Measurements will be performed using the standard tetrapolar technique, with electrodes placed unilaterally on wrist and ankle. The analyzer will apply a current, imperceptible to the subject, and software algorithms in the analyzer will measure resistance and reactance and calculate fat-free mass. The extracellular fluid space will be expressed as a proportion of the estimated TBW. The analysis will take place immediately before HD treatments.
Improvement in patient subjective state
A change (from patient's own baseline) in general well-being, pain, sleep, breathing, energy, appetite, itch, restless legs, and recovery time. These parameters will be measured using the LEVIL, an electronic application based visual analog scale.
Changes in hemodynamic response in hemodialysis
The Finometer utilizes a finger-cuff method to detect beat-to-beat changes in digital arterial diameter using an infrared photoplethysmography. The time averaged data is subsequently downloaded to a computer-based analysis program for analysis. The finger-cuff will be placed on the participants middle finger on the non-vascular access arm pre-dialysis and will remain on throughout the entire study visit.
Proportion of treatment successfully delivering intended ultrafiltration volume with RUF-D
Number of treatments that desired ultrafiltration is achieved.
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