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Design and methods of the REMOVAL-HD study: a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients

Overview of attention for article published in BMC Nephrology, April 2018
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Title
Design and methods of the REMOVAL-HD study: a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients
Published in
BMC Nephrology, April 2018
DOI 10.1186/s12882-018-0883-8
Pubmed ID
Authors

R. Krishnasamy, C. M. Hawley, M. J. Jardine, M. A. Roberts, Y. J. Cho, M. G. Wong, A. Heath, C. L. Nelson, S. Sen, P. F. Mount, E. M. Pascoe, D. Darssan, L. A. Vergara, P. A. Paul-Brent, N. D. Toussaint, D. W. Johnson, C. A. Hutchison

Abstract

Removal of uraemic toxins is inadequate using current dialysis strategies. A new class of dialysis membranes have been developed that allow clearance of larger middle molecules. The REMOVAL-HD study (a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients) will address safety, efficacy and the impact on patient-centred outcomes with the use of a mid cut-off (MCO) dialyser in a chronic haemodialysis (HD) population. REMOVAL-HD is an open label, prospective, non-randomised, single-arm, multi-centre device study in 85 chronic HD participants. All visits will be conducted during regular HD sessions and participants will undergo a 1 month wash-in period using a standardised high flux dialyser, 6 months of intervention with a MCO dialyser and 1 month of wash-out using a high flux dialyser. The primary endpoint is change in pre-dialysis concentrations of serum albumin, with secondary endpoints including the efficacy of clearance of free light chains and β-2 microglobulin, and patient-centred outcomes including quality of life, symptom burden, functional status, nutritional status, hospitalisation and death. MCO dialysers are a novel form of HD membrane. The REMOVAL-HD study is a pivotal study designed to monitor the immediate and medium-term effects following exposure to this dialyser. Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482 . Date of registration - 21/06/2016.

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Mendeley readers

The data shown below were compiled from readership statistics for 51 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 51 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 7 14%
Student > Master 7 14%
Student > Bachelor 5 10%
Researcher 4 8%
Professor 2 4%
Other 7 14%
Unknown 19 37%
Readers by discipline Count As %
Medicine and Dentistry 9 18%
Nursing and Health Professions 9 18%
Sports and Recreations 3 6%
Business, Management and Accounting 2 4%
Computer Science 2 4%
Other 5 10%
Unknown 21 41%