Study the clearance of immunoglobulin free light chains by HDF, lf-HD and high flux hemodialysis (hf-HD) using polysulphone and polyamide dialyzers.
ID
Source
Brief title
Condition
- Immune disorders NEC
- Bacterial infectious disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in change of immunoglobulin free light chain serum concentration
during the hemodialysis session.
Secondary outcome
N.a.
Background summary
In an earlier study we found that immunoglobulin free light chains were better
removed by online hemodiafiltration (HDF) than by low-flux hemodialysis(lf-HD),
it appears that this difference in clearance might be caused by different
membrane materials instead of by the difference in dialysis modality.
Study objective
Study the clearance of immunoglobulin free light chains by HDF, lf-HD and high
flux hemodialysis (hf-HD) using polysulphone and polyamide dialyzers.
Study design
Randomised cross-over study
Intervention
During six consecutive weeks all patients will undergo a midweek hemodialysis
session with each combination of dialysis modality and dialyzer (all common
therapies). Before and after this dialysis session blood samples will be taken
from the lines of the dialysis machine. At two timepoints (lf-HD en HDF with
polysulphone dialyzers) some extra blood will be taken for extra measurements.
Study burden and risks
All study procedures will take place during patients habitual dialysis visits.
Patients that will be included in this study normally undergo lf-HD with
polysulphone membranes. At the midweek dialysis days of 6 consecutive weeks,
they will be switched to the other modalities and dialyzers for one treatment
session. Al these modalities and dialyzers are being used in daily clinical
practice. We will take blood samples (2 tubes) on 6 days, before and after the
dialysis session. Before and after the lf-HD and HDF session with polysulphone
we will take 2 tubes extra blood for storage for other measurements. Patients
do not have to undergo venapunctures, since the blood will be taken from the
dialysis lines.
Groene Hilledijk 315
3075 EA Rotterdam
NL
Groene Hilledijk 315
3075 EA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Prevalent hemodialysis patients, treated with hemodialysis 3 times a week (for at least 2 months) with a minimum dialysis urea Kt/V >= 1.2 and who are able to understand the study procedures.
Exclusion criteria
Exclusion criteria are age < 18 years, treatment by hemodiafiltration or high-flux hemodialysis in the 6 months preceding entering this study, severe incompliance defined as non-adherence to the dialysis prescription and a life expectancy < 3 months due to causes other than kidney disease. Hemoglobin level < 6.0 mmol/L.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36474.101.11 |