A mixed-method feasibility study of a novel transitional regime of incremental haemodialysis: study design and protocol.
Chronic kidney disease
Dialysis
Haemodialysis
Hemodialysis
Incremental HD
Journal
Clinical and experimental nephrology
ISSN: 1437-7799
Titre abrégé: Clin Exp Nephrol
Pays: Japan
ID NLM: 9709923
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
08
03
2021
accepted:
26
04
2021
pubmed:
9
6
2021
medline:
22
1
2022
entrez:
8
6
2021
Statut:
ppublish
Résumé
Incremental haemodialysis/haemodiafiltration (HD) may help reduce early mortality rates in patients starting HD. This mixed-method feasibility study aims to test the acceptability, tolerance and safety of a novel incremental HD regime, and to study its impact on parameters of patient wellbeing. We aim to enrol 20 patients who will commence HD twice-weekly with progressive increases in duration and frequency, achieving conventional treatment times over 15 weeks (incremental group). Participants will be followed-up for 6 months and will undergo regular tests including urine collections, bio-impedance analyses and quality-of-life questionnaires. Semi-structured interviews will be conducted to explore patients' prior expectations from HD, their motivations for participation and experiences of receiving incremental HD. For comparison of safety and indicators of dialysis adequacy, a cohort of 40 matched patients who previously received conventional HD will be constructed from local dialysis records (historical controls). Data will be recorded on the numbers screened and proportions consented and completing the study (primary outcome). Incremental and conventional groups will be compared in terms of differences in blood pressure control, interdialytic weight changes, indicators of dialysis adequacy and differences in adverse and serious adverse events. In analyses restricted to incremental group, measurements of RRF, fluid load and quality-of-life during follow-up will be compared with baseline values. From patient interviews, a narrative description of key themes along with anonymised quotes will be presented. Results from this study will address a significant knowledge gap in the prescription HD therapy and inform the development novel future therapy regimens.
Sections du résumé
BACKGROUND
BACKGROUND
Incremental haemodialysis/haemodiafiltration (HD) may help reduce early mortality rates in patients starting HD. This mixed-method feasibility study aims to test the acceptability, tolerance and safety of a novel incremental HD regime, and to study its impact on parameters of patient wellbeing.
METHOD
METHODS
We aim to enrol 20 patients who will commence HD twice-weekly with progressive increases in duration and frequency, achieving conventional treatment times over 15 weeks (incremental group). Participants will be followed-up for 6 months and will undergo regular tests including urine collections, bio-impedance analyses and quality-of-life questionnaires. Semi-structured interviews will be conducted to explore patients' prior expectations from HD, their motivations for participation and experiences of receiving incremental HD. For comparison of safety and indicators of dialysis adequacy, a cohort of 40 matched patients who previously received conventional HD will be constructed from local dialysis records (historical controls).
RESULTS
RESULTS
Data will be recorded on the numbers screened and proportions consented and completing the study (primary outcome). Incremental and conventional groups will be compared in terms of differences in blood pressure control, interdialytic weight changes, indicators of dialysis adequacy and differences in adverse and serious adverse events. In analyses restricted to incremental group, measurements of RRF, fluid load and quality-of-life during follow-up will be compared with baseline values. From patient interviews, a narrative description of key themes along with anonymised quotes will be presented.
CONCLUSION
CONCLUSIONS
Results from this study will address a significant knowledge gap in the prescription HD therapy and inform the development novel future therapy regimens.
Identifiants
pubmed: 34101030
doi: 10.1007/s10157-021-02072-1
pii: 10.1007/s10157-021-02072-1
pmc: PMC8421284
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1131-1141Informations de copyright
© 2021. The Author(s).
Références
Nephrol Dial Transplant. 2005 Apr;20(4):671-3
pubmed: 15755759
Trials. 2020 Feb 19;21(1):206
pubmed: 32075665
J Nephrol. 2019 Oct;32(5):823-836
pubmed: 30604150
Kidney Int. 2016 Nov;90(5):1071-1079
pubmed: 27528548
BMJ Open. 2020 Aug 13;10(8):e035919
pubmed: 32792431
Nephrol Dial Transplant. 2020 Aug 1;35(8):1420-1425
pubmed: 32040147
Clin J Am Soc Nephrol. 2010 Jun;5(6):1036-40
pubmed: 20507952
N Engl J Med. 2015 Jul 16;373(3):232-42
pubmed: 26052984
Kidney Med. 2019 Nov 01;1(6):332-334
pubmed: 33015607
Hemodial Int. 2014 Apr;18(2):415-22
pubmed: 24467830
Am J Kidney Dis. 2003 Sep;42(3):474-85
pubmed: 12955675
J Am Soc Nephrol. 2016 Oct;27(10):2955-2963
pubmed: 27401689
Kidney Int. 2002 Sep;62(3):1046-53
pubmed: 12164889
BMC Nephrol. 2014 Oct 29;15:172
pubmed: 25352299
Clin Kidney J. 2015 Jun;8(3):271-7
pubmed: 26034587
Semin Dial. 2016 Nov;29(6):476-480
pubmed: 27561174
Nephrol Dial Transplant. 2017 Feb 1;32(2):355-363
pubmed: 28186541
Nephrology (Carlton). 2019 Apr;24(4):438-444
pubmed: 29532551
Kidney Int Rep. 2020 Sep 09;5(11):1856-1869
pubmed: 33163709
Adv Chronic Kidney Dis. 2018 Jan;25(1):93-104
pubmed: 29499893
Clin J Am Soc Nephrol. 2010 Jan;5(1):72-9
pubmed: 19965531
Nephrol Dial Transplant. 2001 Jun;16(6):1132-8
pubmed: 11390711
Nephrol Dial Transplant. 2018 Mar 1;33(3):530-539
pubmed: 28340192
Hemodial Int. 2017 Oct;21 Suppl 2:S41-S46
pubmed: 29064172
J Am Soc Nephrol. 1995 Nov;6(5):1386-91
pubmed: 8589313
Semin Dial. 2017 Jan;30(1):39-49
pubmed: 27757995
Curr Opin Nephrol Hypertens. 2019 Nov;28(6):641-647
pubmed: 31369421
Clin J Am Soc Nephrol. 2009 Dec;4 Suppl 1:S5-11
pubmed: 19996006
Clin Ther. 1996 Sep-Oct;18(5):887-938
pubmed: 8930432
N Engl J Med. 2009 Oct 15;361(16):1539-47
pubmed: 19828531
Ther Apher Dial. 2020 Jun;24(3):275-284
pubmed: 31574577
Am J Kidney Dis. 2020 Apr;75(4):465-467
pubmed: 32008858
Kidney Int. 2014 Aug;86(2):392-8
pubmed: 24522495
Clin J Am Soc Nephrol. 2007 Jan;2(1):89-99
pubmed: 17699392
OTJR (Thorofare N J). 2015 Jul;35(3):169-77
pubmed: 26594739
Am J Kidney Dis. 2003 Jul;42(1):125-32
pubmed: 12830464
Semin Dial. 2017 May;30(3):262-269
pubmed: 28295607
Clin J Am Soc Nephrol. 2013 Dec;8(12):2174-82
pubmed: 23970134
Biomed Phys Eng Express. 2017 May 25;3(3):
pubmed: 28824817
Clin J Am Soc Nephrol. 2010 Jun;5(6):954-5
pubmed: 20507956
Nephrol Dial Transplant. 2019 Nov 1;34(11):1806-1811
pubmed: 30805639
Ther Innov Regul Sci. 2018 Sep;52(5):546-559
pubmed: 29909645
Int J Artif Organs. 1989 Mar;12(3):159-64
pubmed: 2744875
Clin Med Res. 2021 Jun;19(2):54-63
pubmed: 33582647
J Am Soc Nephrol. 2016 Oct;27(10):2948-2954
pubmed: 27283497
Nephrology (Carlton). 2019 Nov;24(11):1172-1178
pubmed: 30632257
Semin Dial. 2018 Jul;31(4):343-352
pubmed: 29737013
Pilot Feasibility Stud. 2016 Oct 21;2:64
pubmed: 27965879
Kidney Int. 2012 Aug;82(4):382-7
pubmed: 22534960
Kidney Int. 2016 Nov;90(5):936-938
pubmed: 27645102
Nephrol Dial Transplant. 2019 Jun 1;34(6):1017-1025
pubmed: 30357360
Clin J Am Soc Nephrol. 2008 Jan;3(1):19-26
pubmed: 18003765
Kidney Int. 2014 Jan;85(1):12-4
pubmed: 24380902
Nutr Clin Pract. 2007 Aug;22(4):389-405
pubmed: 17644693
Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii22-44
pubmed: 17507425