Association of middle molecules clearance with HDF volume.
Research type
Research Study
Full title
Association of middle molecules clearance and clinical parameters with haemodiafiltration convection volume.
IRAS ID
336020
Contact name
Usama Butt
Contact email
Sponsor organisation
East and North Hertfordshire NHS trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
People with severe kidney failure need treatment by dialysis or transplantation to stay alive. In the UK there are 25,000 people receiving treatment with haemodialysis (HD). Conventional haemodialysis works on the principle of diffusion for removal of toxins. Haemodiafiltration (HDF) is a technique of dialysis which implies the principle of convection in addition to diffusion. Large clinical trials comparing haemodiafiltration with conventional haemodialysis have reported better survival in patients having haemodiafiltration with large convection volume. The mechanism of survival benefit with high convection volume remains unclear.
We hypothesize that the benefit of high convection volume haemodiafiltration is due to enhanced removal of large sized toxins called ‘middle molecules’. Additionally, it may also be due to better blood pressure control and less inflammation when dialysing using this technique. The literature so far has been inconsistent to confirm this.
Understanding the relationship of haemodiafiltration convection volume with middle molecules removal and clinical parameters is crucial for adoption of this mode of treatment. Additionally, it can potentially transform the presently imperfect dialysis prescription based on small molecule removal to clinically relevant middle molecules removal.
In this single centre cross sectional study, we aim to recruit 400 adult participants who have been on haemodiafiltration for at least 3 months. Once consented, they will be observed in a single routine dialysis sessions (study visit) to record all the standard care clinical parameters and dialysis related information including dialysis convection volume from haemodiafiltration. They will also have routine blood tests at the start and end of the observed dialysis session and additional blood tests to measure the removal of middle molecules at the same time. The relationship of these observed clinical and measured toxins removal parameters with convection volume will be determined from the collected data.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0294
Date of REC Opinion
9 Jan 2024
REC opinion
Further Information Favourable Opinion