Adequacy of HDF
Research type
Research Study
Full title
Adequacy of Haemodiafiltration : Middle molecules clearance, patients reported outcomes and sodium balance.
IRAS ID
348018
Contact name
Usama Butt
Contact email
Sponsor organisation
East and North Hertfordshire NHS trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
In the UK there are over 25,000 people with end stage kidney disease (ESKD) receiving treatment with haemodialysis (HD).Dialysis efficiency is determined by measuring the removal of small molecules (urea) during the dialysis session. This method of measuring dialysis adequacy was established 4 decades ago. There has been significant evolution in dialysis since then. Modern dialysis employs convective treatment (HDF) which removes large molecular sized toxins such as β2-Microglobulin (β2M) and appear to have survival benefit as compared to conventional HD. Despite the evolution in dialysis, the measure of dialysis quality has not evolved and still is based on urea clearance. To develop a metric of dialysis adequacy which is in line with current dialysis practice is the next logical step. There are multiple aspects of dialysis efficiency including toxins clearance, nutritional status, bone mineral metabolism, fluid status and dialysis symptoms burden. This study aims to develop a tool of dialysis efficiency which encompasses all these aspects.
In this observational study we aim to recruit 300 adult patient with 20% - 25% on conventional HD and rest receiving HDF. All participants will have one year follow up with 3 study visits 6 months apart. During the study visit , the research team will record their standard care observations, dialysis parameters and results from standard care blood and urine tests. The participants will also have research procedures including fluid status assessment, research blood tests for β2M , nutritional assessment and symptoms questionnaires. All study activities will be performed during the participant's routine dialysis sessions. The data obtained will be analysed to understand the relationship between HDF convection volume and β2M clearance with clinical , biochemical and patient reported outcomes. The study will also explore the relationship of sodium concentration in dialysis fluid (dialysate) with volume status of the patients on HD and HDF.REC name
London - Central Research Ethics Committee
REC reference
24/PR/1131
Date of REC Opinion
30 Sep 2024
REC opinion
Further Information Favourable Opinion