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A tRial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in HemoDialysis Patients: A Safety Device Study.
Blood Purif 2020; :1-11BP

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.

Authors+Show Affiliations

Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia, Rathika.Krishnasamy@health.qld.gov.au. Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia, Rathika.Krishnasamy@health.qld.gov.au. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia, Rathika.Krishnasamy@health.qld.gov.au.Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia. The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia. San Renal Dialysis Unit, Sydney Adventist Hospital, Sydney, New South Wales, Australia. Department of Nephrology, Concord Repatriation and General Hospital, Sydney, New South Wales, Australia.Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia. Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.The George Institute for Global Health, UNSW, Sydney, New South Wales, Australia. San Renal Dialysis Unit, Sydney Adventist Hospital, Sydney, New South Wales, Australia.San Renal Dialysis Unit, Sydney Adventist 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.Department of Nephrology, Concord Repatriation and General Hospital, Sydney, New South Wales, Australia.Department of Nephrology, Austin Health, Melbourne, Victoria, Australia.Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia. Department of Medicine (RMH), The University of Melbourne, Parkville, Victoria, Australia.Center for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia. Department of Medicine, Hawke's Bay Hospital, Hawkes Bay, New Zealand.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31968346

Citation

Krishnasamy, Rathika, et al. "A tRial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in HemoDialysis Patients: a Safety Device Study." Blood Purification, 2020, pp. 1-11.
Krishnasamy R, Hawley CM, Jardine MJ, et al. A tRial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in HemoDialysis Patients: A Safety Device Study. Blood Purif. 2020.
Krishnasamy, R., Hawley, C. M., Jardine, M. J., Roberts, M. A., Cho, Y., Wong, M., ... Hutchison, C. A. (2020). A tRial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in HemoDialysis Patients: A Safety Device Study. Blood Purification, pp. 1-11. doi:10.1159/000505567.
Krishnasamy R, et al. A tRial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in HemoDialysis Patients: a Safety Device Study. Blood Purif. 2020 Jan 22;1-11. PubMed PMID: 31968346.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A tRial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in HemoDialysis Patients: A Safety Device Study. AU - Krishnasamy,Rathika, AU - Hawley,Carmel M, AU - Jardine,Meg J, AU - Roberts,Matthew A, AU - Cho,Yeoungjee, AU - Wong,Muhgeot, AU - Heath,Anne, AU - Nelson,Craig L, AU - Sen,Shaundeep, AU - Mount,Peter F, AU - Pascoe,Elaine M, AU - Vergara,Liza A, AU - Paul-Brent,Peta-Anne, AU - Toussaint,Nigel D, AU - Johnson,David W, AU - Hutchison,Colin A, Y1 - 2020/01/22/ PY - 2019/08/27/received PY - 2019/12/19/accepted PY - 2020/1/23/entrez PY - 2020/1/23/pubmed PY - 2020/1/23/medline KW - Albumin KW - Dialysis membrane KW - Dialyzer KW - Efficacy KW - Free light chains KW - Hemodialysis KW - Mid cut-off KW - Safety SP - 1 EP - 11 JF - Blood purification JO - Blood Purif. N2 - 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. SN - 1421-9735 UR - https://www.unboundmedicine.com/medline/citation/31968346/A_tRial_Evaluating_Mid_Cut-Off_Value_Membrane_Clearance_of_Albumin_and_Light_Chains_in_HemoDialysis_Patients:_A_Safety_Device_Study L2 - https://www.karger.com?DOI=10.1159/000505567 DB - PRIME DP - Unbound Medicine ER -