Does NIGHT-time dialysis improve quality of LIFE?

Not Applicable

• Conditions: Haemodialysis, renal failure; Urological and Genital Diseases; Haemodialysis (or haemodiafiltration), kidney dialysis, kidney failure, renal failure

• Registration Number: ISRCTN87042063
• Lead Sponsor: niversity of Leicester

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-14
• Last Update Posted: 1 April 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

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

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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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 17/02/2023: <br><br>Kidney Disease Quality of Life (KDQoL) total score (calculated from the KDQoL-SF questionnaire) measured over 6 months<br><br>_____<br><br>Previous primary outcome measure:<br><br>Quality of life measured using the composite score from the Kidney Disease Quality of Life tool (KDQoL) at 6 months