Abstract: TH-PO353
Trial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in Hemodialysis Patients (REMOVAL-HD): A Safety and Efficacy Study
Session Information
- Dialysis: Dialysate and Clearance
October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Krishnasamy, Rathika, Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia
- Hutchison, Colin A., Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia
Group or Team Name
- on behalf of the REMOVAL-HD investigators
Background
A medium cut-off (MCO) dialyzer is a novel form of hemodialysis (HD) therapy designed to increase clearances of larger middle molecules and uremic toxins but may result in short-term loss of albumin. The safety and efficacy profile following sustained use of this dialyzer has not been established.
Methods
REMOVAL-HD is an investigator led, single-arm, multi-center device study that examined the safety, efficacy and patient-centered outcomes of MCO dialyzer use in chronic HD patients over 6 months. The primary outcome was change in serum albumin between baseline and 6 months. Secondary outcomes included 4-weekly trends in serum albumin, six-minute walk test (6MWT), malnutrition inflammation score (MIS) and symptom burden using restless leg syndrome rating scale and Edmonton Symptom Assessment System Revised (ESAS-R) measured at baseline, 3 and 6 months.
Results
Of 92 enrolled participants, 87 completed the required protocol and were included for analysis. Participants had a mean age of 67± 15 years, 63% were men and 51% were diabetic. The average serum albumin decreased by 1.06 g/L (95% confidence interval [CI] 0.43,1.69], or 2.92%, from baseline. The trend in serum albumin during the intervention period is shown in Figure 1. A sustained, unexplained reduction in serum albumin (>25%) was not observed in any participant. Functional and nutritional assessment using 6MWT (Δ5.7m 95% CI -29.9, 41.3) and MIS (Δ-0.4 95%CI -0.9, 0.1) were stable throughout the treatment period. Similarly, there was no significant change in patient-reported symptom burden.
Conclusion
Regular HD using the MCO dialyzer in a chronic HD population resulted in a small but acceptable reduction in serum albumin. Future randomised controlled trials should now assess the impact of the MCO dialyzer on clinical and long-term patient-centered outcomes.
Trend in serum albumin under MCO dialyzer use
Funding
- Commercial Support –