Rathika Krishnasamy1,2,3, Carmel M Hawley4,5,6, Meg J Jardine5,7,8,9, Matthew A Roberts5,10, Yeoungjee Cho4,5,6, Muhgeot Wong7,8, Anne Heath8, Craig L Nelson11,12,13, Shaundeep Sen9, Peter F Mount14, Elaine M Pascoe4,5, Liza A Vergara5, Peta-Anne Paul-Brent5, Nigel D Toussaint15,16, David W Johnson4,5,6, Colin A Hutchison5,17. 1. Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia, Rathika.Krishnasamy@health.qld.gov.au. 2. Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia, Rathika.Krishnasamy@health.qld.gov.au. 3. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia, Rathika.Krishnasamy@health.qld.gov.au. 4. Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia. 5. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia. 6. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia. 7. The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia. 8. San Renal Dialysis Unit, Sydney Adventist Hospital, Sydney, New South Wales, Australia. 9. Department of Nephrology, Concord Repatriation and General Hospital, Sydney, New South Wales, Australia. 10. Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia. 11. Department of Nephrology, Western Health, Melbourne, Victoria, Australia. 12. Department of Medicine, Western Health, University of Melbourne, Melbourne, Victoria, Australia. 13. Western Health Chronic Disease Alliance, Western Centre for Health Research and Education, Western Health, St Albans, Victoria, Australia. 14. Department of Nephrology, Austin Health, Melbourne, Victoria, Australia. 15. Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia. 16. Department of Medicine (RMH), The University of Melbourne, Parkville, Victoria, Australia. 17. Department of Medicine, Hawke's Bay Hospital, Hawkes Bay, New Zealand.
Abstract
BACKGROUND: A new class of dialysis membrane, the mid cut-off (MCO) dialyzer, has been developed to improve the clearance of uremic toxins in hemodialysis (HD). The a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HemoDialysis patients (REMOVAL-HD) study aimed to determine if regular use of MCO dialyzer was safe and specifically did not result in a significant loss of albumin. METHODS: This investigator initiated, crossover, longitudinal, device study was conducted across 9 centers in Australia and New Zealand (n = 89). Participants had a 4-week wash-in with high-flux HD, followed by 24-week intervention with MCO HD and a subsequent 4-week wash-out with high-flux HD. The primary outcome was change in serum albumin between weeks 4 and 28. Secondary outcomes included trends in serum albumin, changes in kappa- and lambda-free light chains (FLC), 6-min walk test (6MWT), malnutrition inflammation score (MIS), restless legs score and quality of life. RESULTS: Participants had a mean age of 66 ± 14 years, 62% were men, 45% were anuric, and 51% had -diabetes. There was no reduction in serum albumin following treatment with MCO HD (mean reduction -0.7 g/L, 95% CI -1.5 to 0.1). A sustained, unexplained reduction in serum albumin (>25%) was not observed in any participant. A reduction in FLC was observed 2 weeks into MCO HD (lambda-FLC: Δ -9.1 mg/L, 95% CI -14.4 to -3.7; kappa-FLC: Δ -5.7 mg/L, 95% CI -9.8 to -1.6) and was sustained for the rest of the study intervention. Both FLC increased after the cessation of MCO use. There was no improvement in restless legs symptoms, quality of life, 6MWT or MIS scores. CONCLUSIONS: Regular HD using the MCO dialyzer did not result in a significant fall in serum albumin. There were no effects on quality of life, functional status or nutrition. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482.
BACKGROUND: A new class of dialysis membrane, the mid cut-off (MCO) dialyzer, has been developed to improve the clearance of uremic toxins in hemodialysis (HD). The a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HemoDialysis patients (REMOVAL-HD) study aimed to determine if regular use of MCO dialyzer was safe and specifically did not result in a significant loss of albumin. METHODS: This investigator initiated, crossover, longitudinal, device study was conducted across 9 centers in Australia and New Zealand (n = 89). Participants had a 4-week wash-in with high-flux HD, followed by 24-week intervention with MCO HD and a subsequent 4-week wash-out with high-flux HD. The primary outcome was change in serum albumin between weeks 4 and 28. Secondary outcomes included trends in serum albumin, changes in kappa- and lambda-free light chains (FLC), 6-min walk test (6MWT), malnutrition inflammation score (MIS), restless legs score and quality of life. RESULTS:Participants had a mean age of 66 ± 14 years, 62% were men, 45% were anuric, and 51% had -diabetes. There was no reduction in serum albumin following treatment with MCO HD (mean reduction -0.7 g/L, 95% CI -1.5 to 0.1). A sustained, unexplained reduction in serum albumin (>25%) was not observed in any participant. A reduction in FLC was observed 2 weeks into MCO HD (lambda-FLC: Δ -9.1 mg/L, 95% CI -14.4 to -3.7; kappa-FLC: Δ -5.7 mg/L, 95% CI -9.8 to -1.6) and was sustained for the rest of the study intervention. Both FLC increased after the cessation of MCO use. There was no improvement in restless legs symptoms, quality of life, 6MWT or MIS scores. CONCLUSIONS: Regular HD using the MCO dialyzer did not result in a significant fall in serum albumin. There were no effects on quality of life, functional status or nutrition. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482.
Authors: Fernando Hadad-Arrascue; Lars-Göran Nilsson; Angela S Rivera; Angelito A Bernardo; Juan B Cabezuelo Romero Journal: Ther Apher Dial Date: 2021-06-29 Impact factor: 2.195
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