Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515899
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-16
Brief Title:
Association of Middle Molecules Clearance With HDF Volume
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Association of Middle Molecules Clearance and Clinical Parameters With Haemodiafiltration Convection Volume
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
People with severe kidney failure need treatment by dialysis or transplantation to stay alive In the UK there are 25000 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
The investigators 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 the investigators aim to recruit 400 adult participants who have been on haemodiafiltration for at least 3 months Once consented the participants 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 Participants 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
The investigators 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 the investigators aim to recruit 400 adult participants who have been on haemodiafiltration for at least 3 months Once consented the participants 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 Participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None