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Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes


- candidate number27782
- NTR NumberNTR6736
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-aug-2017
- Secondary IDsvolgt volgt
- Public TitleDutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes
- Scientific TitleDutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes: quality-of-life, clinical outcomes and cost-effectiveness of home dialysis
- ACRONYMDOMESTICOpro
- hypothesisHome dialysis results in improvement of quality of life, at least comparable clinical outcomes and lower costs, compared to in-centre HD.
- Healt Condition(s) or Problem(s) studiedRenal disease, Kidney damage, Hemodialysis, Peritoneal dialysis, Quality of life, Home dialysis
- Inclusion criteria- Age > 18 years
- indication to start with RRT
- willingness to start with a form of RRT
- Exclusion criteria- unwillingness to provide informed consent
- life expectancy < 3 months
- expected renal transplantation < 3 months
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 20-dec-2017
- planned closingdate20-jun-2022
- Target number of participants1600
- InterventionsHome dialysis, both peritoneal dialysis and home haemodialysis
- Primary outcomeQuality of life, obtained from the following questionnaires: SF-12, Dialysis Symptom Index and EQ5D-5L
- Secondary outcomeclinical outcomes (phosphate and anaemia control, nutritional status, infectious complications, hospitalisation, mortality) and cost-effectiveness.
- Timepointsbaseline, 3 months, 6 months, and every 6 months thereafter until end of follow-up or end of study.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. B.C. Jaarsveld, van
- CONTACT for SCIENTIFIC QUERIESDr. B.C. Jaarsveld, van
- Sponsor/Initiator VU University Medical Center, University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Baxter, Fresenius Medical Care, ZonMw
- Publications
- Brief summaryEnd-stage renal disease (ESRD) is a common and costly health care problem affecting all age groups.
Although the absolute number of patients treated with dialysis in The Netherlands is low (6500 dialysis patients in 2016), it is by far the largest cost-consumer of all treatment modalities in general.
Most dialysis patients are treated 3 times a week during 4 hours with haemodialysis at a dialysis centre (conventional in-centre HD). However, dialysis can also be performed at home, in the form of peritoneal dialysis (PD) or home HD. Dialysis treatment at home is considered to be at least equally effective regarding survival. However, the percentage of patients treated with a form of home dialysis (either PD or home HD) has steadily decreased over the past 15 years in The Netherlands, from 33% in 2002 to 18% in 2016 (www.nefrodata.nl). This decline is mainly attributable to a reduction in the number of PD patients, due to pre-emptive transplantation.

Starting dialysis has major impact on QoL of patients. However, recent available evidence regarding the effects of home dialysis on QoL compared with in-centre HD is limited and outdated. The studies are small and all have a cross-sectional design. Furthermore, patients starting with a form of home dialysis have changed remarkably over the past years: home dialysis patients used to be young, employed and with little comorbidities, whereas during the last years the general home dialysis population is older and suffers from cardiovascular disease. Therefore, an update of older data on clinical outcomes of home dialysis in relation to in-centre HD is necessary.
- Main changes (audit trail)
- RECORD22-aug-2017 - 21-okt-2017


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