Association of Middle Molecules Clearance With HDF Volume

NCT06515899 | Recruiting

• 1 other identifier: RD2023-68
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

HDF is a dialysis technique which involves diffusion and convection. HDF with high convection volume has consistently shown to improve survival in dialysis patients in number of robust RCTs. The precise reason of this survival benefit remains unclear. The investigators hypothesize that this survival benefit with high volume HDF is related to enhanced middle molecule clearance and hemodynamic stability. However, this relationship has not been studied so far. This observational study is aimed to understand the relationship between HDF convection volume with middle molecules (Beta 2-Microglobulin) clearance during HDF. Exploring the relationship of HDF volume with middle molecules clearance has significant clinical ramifications. Only a minority of patients are able to achieve target convection volume. Understanding these relationships can rationalize the HDF prescription from convection volume-based prescription to β2-Microglobulin clearance-based prescription which may be applicable to wider range of patients. The relationship between pre-dialysis β2-Microglobulin levels and RKF offers the prospect of dispensing with pre- and post-dialysis urea and creatinine measurements and interdialytic urine collections, currently necessary for estimating RKF, thus simplifying its estimation. β2-Microglobulin reduction ratio and its component pre and post-dialysis β2-Microglobulin levels could therefore provide a composite estimate of small and middle molecule clearance and RKF.

Conditions

End Stage Renal Disease

Keywords

Middle Molecules clearance in HDF; HDF; Middle molecules; beta 2 microglobulin; HDF convection volume

Outcome Measures

Primary Outcomes (2)

• The relationship between HDF convection volume and β2 Microglobulin reduction ratio during a HDF session.

  18 months

• The relationship between HDF convection volume and serum pre dialysis β2 Microglobulin concentration (measured in mg/L).

  18 months

Secondary Outcomes (3)

• The relationship of HDF convection volume with average intradialytic blood pressure (mmHg).

  18 months

• The relationship of HDF convection volume with average intradialytic core body temperature (degrees centigrade)

  18 months

• The relationship of HDF convection volume with CRP (mg/L).

  18 months

Study Arms (1)

HDF patients

ESRF patients who are receiving renal replacement therapy in the form of HDF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End stage renal failure patient having renal replacement therapy in the form of Haemodiafiltration.

You may qualify if:

• 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

You may not qualify if:

• Age less than 18 years.
• Inability to give informed consent.
• Prognosis less than 6 months as assessed by PI

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Study Sites (1)

East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Usama A Butt, MBBS, MRCP

  East and North Hertfordshire NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Usama A Butt, MBBS,MRCP

CONTACT

+441438284340; usama.butt1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: July 23, 2024
• Study Start: January 19, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)