Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.
Adequacy of dialysis
hemodialysis
hemodialysis delivery systems
home
kinetics
volume control
Journal
Hemodialysis international. International Symposium on Home Hemodialysis
ISSN: 1542-4758
Titre abrégé: Hemodial Int
Pays: Canada
ID NLM: 101093910
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
19
07
2019
revised:
17
09
2019
accepted:
24
09
2019
pubmed:
8
11
2019
medline:
22
8
2020
entrez:
8
11
2019
Statut:
ppublish
Résumé
Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers. A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/V Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/V Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.
Identifiants
pubmed: 31697042
doi: 10.1111/hdi.12795
pmc: PMC7027451
doi:
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
22-28Informations de copyright
© 2019 Outset Medical. Hemodialysis International published by Wiley Periodicals, Inc. on behalf of International Society for Hemodialysis.
Références
Nephrol Dial Transplant. 2008 Oct;23(10):3283-9
pubmed: 18458034
JAMA. 2007 Sep 19;298(11):1291-9
pubmed: 17878421
Am J Kidney Dis. 2016 Apr;67(4):617-28
pubmed: 26561355
J Am Soc Nephrol. 2012 May;23(5):895-904
pubmed: 22362906
Clin J Am Soc Nephrol. 2011 May;6(5):1049-56
pubmed: 21415315
Nephrol Dial Transplant. 2011 Jul;26(7):2316-22
pubmed: 21421590
Kidney Int. 2009 Nov;76(9):984-90
pubmed: 19692997
N Engl J Med. 2010 Dec 9;363(24):2287-300
pubmed: 21091062
Nephrol Dial Transplant. 2013 Aug;28(8):2156-60
pubmed: 22561585
Clin Transplant. 2009 Jan-Feb;23(1):47-55
pubmed: 18786137
Am J Kidney Dis. 2010 Sep;56(3):531-9
pubmed: 20673601
Hemodial Int. 2016 Oct;20(4):643-649
pubmed: 27194590
Semin Dial. 2004 Mar-Apr;17(2):118-24
pubmed: 15043613
Clin J Am Soc Nephrol. 2009 Apr;4(4):784-9
pubmed: 19339408
J Am Soc Nephrol. 2012 Apr;23(4):696-705
pubmed: 22362910
Kidney Int. 2003 Sep;64(3):1004-11
pubmed: 12911550
Int Urol Nephrol. 2010 Sep;42(3):759-64
pubmed: 20563843
Am J Kidney Dis. 2002 Sep;40(3):611-22
pubmed: 12200814