Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/22493
Title: A tRial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in HemoDialysis Patients: A Safety Device Study.
Authors: Krishnasamy, Rathika;Hawley, Carmel M;Jardine, Meg J;Roberts, Matthew A;Cho, Yeoungjee;Wong, Muhgeot;Heath, Anne;Nelson, Craig L;Sen, Shaundeep;Mount, Peter F;Pascoe, Elaine M;Vergara, Liza A;Paul-Brent, Peta-Anne;Toussaint, Nigel D;Johnson, David W;Hutchison, Colin A
Affiliation: Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia
Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia
Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia
Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia
San Renal Dialysis Unit, Sydney Adventist Hospital, Sydney, New South Wales, Australia
The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia
Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia
Department of Medicine, Hawke's Bay Hospital, Hawkes Bay, New Zealand..
Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia
Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia
Department of Medicine (RMH), The University of Melbourne, Parkville, Victoria, Australia
Department of Nephrology, Austin Health, Heidelberg, Victoria, Australia
Department of Nephrology, Concord Repatriation and General Hospital, Sydney, New South Wales, Australia
Department of Nephrology, Western Health, Melbourne, Victoria, Australia
Department of Medicine, Western Health, University of Melbourne, Melbourne, Victoria, Australia
Western Health Chronic Disease Alliance, Western Centre for Health Research and Education, Western Health, St Albans, Victoria, Australia
Issue Date: 22-Jan-2020
EDate: 2020-01-22
Citation: Blood purification 2020; online first: 22 January
Abstract: 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. 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. 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. 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. Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482.
URI: http://ahro.austin.org.au/austinjspui/handle/1/22493
DOI: 10.1159/000505567
ORCID: 0000-0001-7637-3661
PubMed URL: 31968346
Type: Journal Article
Subjects: Albumin
Dialysis membrane
Dialyzer
Efficacy
Free light chains
Hemodialysis
Mid cut-off
Safety
Appears in Collections:Journal articles

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