Understanding how HDF volume affects middle molecule clearance in dialysis patients
Association of Middle Molecules Clearance and Clinical Parameters With Haemodiafiltration Convection Volume
East and North Hertfordshire NHS Trust · NCT06515899
This study is trying to see if using more fluid in a specific type of dialysis can help patients with kidney failure clear harmful substances from their blood better and improve their survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East and North Hertfordshire NHS Trust (other gov) |
| Locations | 1 site (Stevenage, Hertfordshire) |
| Trial ID | NCT06515899 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between the volume of convection in haemodiafiltration (HDF) and the clearance of middle molecules, specifically beta 2-microglobulin, in patients with end-stage renal disease. The hypothesis is that higher convection volumes in HDF may lead to better survival rates due to enhanced clearance of these larger toxins. By recruiting 400 adult participants who have been on HDF for at least three months, the study seeks to clarify the mechanisms behind the survival benefits associated with high-volume HDF. The findings could lead to a shift in dialysis prescription practices from focusing on small molecule removal to prioritizing middle molecule clearance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above with end-stage renal failure who have been on haemodiafiltration for at least three months.
Not a fit: Patients who are under 18 years old or have a prognosis of less than six months will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dialysis prescriptions that enhance patient survival and quality of life.
How similar studies have performed: While there have been robust randomized controlled trials showing survival benefits with high-volume HDF, the specific relationship between HDF convection volume and middle molecule clearance has not been extensively studied, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or above. * Ability to give informed consent. * End stage renal failure treated by dialysis for at least 3 months. * Established on hemodiafiltration for \>4 weeks. * Prognosis more than 6 months as assessed by PI Exclusion Criteria: * Age less than 18 years. * Inability to give informed consent. * Prognosis less than 6 months as assessed by PI
Where this trial is running
Stevenage, Hertfordshire
- East and North Hertfordshire NHS Trust — Stevenage, Hertfordshire, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Usama A Butt, MBBS, MRCP — East and North Hertfordshire NHS Trust
- Study coordinator: Usama A Butt, MBBS,MRCP
- Email: usama.butt1@nhs.net
- Phone: +441438284340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Renal Disease, Middle Molecules clearance in HDF, HDF, Middle molecules, beta 2 microglobulin, HDF convection volume