A randomised controlled trial assessing the effectiveness and cost effectiveness of thrice weekly, extended, in-centre nocturnal haemodialysis versus daytime haemodialysis using a mixed methods approach

niversity of Leicester0 个研究点目标入组 350 人开始时间: 2020年7月14日最近更新: 2024年4月1日

适应症

试验速览

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37573352/ (added 14/08/2023)

•1. Patients established on haemodialysis for =3 months (i.e. prevalent dialysis patients)
•2. Aged =18 years
•3. Able to give informed consent
•4. Able to participate fully in the interventions and follow-up procedures

•Current exclusion criteria as of 14/05/2021:
•1. Currently on in-centre nocturnal dialysis, or less than 3 months since stopping
•2. Less than 3 months since stopping daily extended daytime or nocturnal dialysis
•3. Patients for whom extended dialysis is clinically indicated (e.g. calciphylaxis, pregnancy)
•4. Scheduled for living donor kidney transplant
•5. Plans to change dialysis modality or centre in the next 6 months
•6. Life expectancy of <6 months
•7. Current participation in an interventional trial with conflicting therapies or primary outcomes
•Previous exclusion criteria:
•1. Currently on in-centre nocturnal dialysis, or less than 3 months since stopping
•2. Less than 3 months since stopping daily extended daytime or nocturnal dialysis
•3. Patients for whom extended dialysis is clinically indicated randomisation to standard hours care of 4 h thrice weekly during the day would be clinically unacceptable (e.g. calciphylaxis, pregnancy)
•4. Scheduled for living donor kidney transplant
•5. Plans to change dialysis modality or centre in the next 6 months
•6. Life expectancy of <6 months
•7. Current participation in an interventional trial with conflicting therapies or primary outcomes

发起方

niversity of Leicester