Complication of Hemodialysis Clinical Trial
— RECORDEROfficial title:
REmoval of Free Light Chains in Hemodialysis Patients Without Multiple Myeloma. A Crossover COmpaRison of Three Different dialyzERs
NCT number | NCT02950389 |
Other study ID # | 2016/GD/2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | July 2016 |
Verified date | March 2021 |
Source | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing impairment of neutrophil function can contribute to the chronic inflammation state of uremic patients, and the increased risk of bacterial infections or vascular calcifications. The aim of this crossover observational study was to assess the difference in free light chain removal by three different hemodialysis filters in patients not affected by multiple myeloma. Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane Filtryzer BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7 High Performance dialysers (HPS). Twenty chronic hemodialysis patients were enrolled. The patients were randomized into two groups of treatment lasting six weeks each. The dialysis sessions checked were the midweek sessions and the blood was drawn at times 0, 120' and 240'. Kappa (k) and lambda (l) light chain levels, beta2microglobulin (β2M), C reactive protein (CRP) and albumin were checked.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - chronic hemodialysis patients - free light chain values >100 mg/L for k chains or >50 mg/L for lambda chains. - absence or <200 ml/die residual diuresis - fistula or central venous catheter with blood flow >250 ml/min. Exclusion Criteria: - intradialytic hypotension - multiple myeloma - poly-allergy - HIV positivity |
Country | Name | City | State |
---|---|---|---|
Italy | Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital | Bologna |
Lead Sponsor | Collaborator |
---|---|
IRCCS Azienda Ospedaliero-Universitaria di Bologna |
Italy,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare free light chain removal by three different hemodialysis filters in a cohort of chronic dialysis patients not affected by multiple myeloma | 45 days | ||
Secondary | Compare beta 2 microglobulin removal by three different hemodialysis filters | 45 days |
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