REmoval of Free Light Chains in Hemodialysis Patients Without Multiple Myeloma. A Crossover COmpaRison of Three Different dialyzERs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Compare free light chain removal by three different hemodialysis filters in a cohort of chronic dialysis patients not affected by multiple myeloma
研究概览
简要总结
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.
详细描述
Background. Immunoglobulin light chains are classified as middle molecule uremic toxins together with β2M and parathyroid hormon. They have a mean molecular weight of 25,000 daltons for monomers (k free light chains) and approximately 50,000 daltons for dimers (lambda free light chains).
Raised serum levels of polyclonal free light chains can impair neutrophil function in terms of: 1) inhibited chemotactic movement; 2) reduced activation of glucose uptake; 3) inhibited apoptosis.
Immunoglobulin light chains are 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 to the increased risk of bacterial infection. Desjardins et al. demonstrated an association between free light chain levels and vascular calcification progression in chronic kidney disease patients. Nonetheless, serum free light chains in patients with chronic kidney disease are associated with the risk of end stage renal disease and death.
It seems that high flux PMMA membranes significantly reduce the light chain level, presumably due to adsorption. This behavior has led to the use of PMMA in the removal of monoclonal free light chains during multiple myeloma.
Preliminary reports describe a significant reduction in free light chains also during hemodiafiltration with reinfusion of endogenous ultrafiltrate (on-line HFR). A recent paper by Borrelli et al. reported an improvement in chronic inflammation after chronic online HFR in dialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •intradialytic hypotension
- •multiple myeloma
- •poly-allergy
- •HIV positivity
结局指标
主要结局
Compare free light chain removal by three different hemodialysis filters in a cohort of chronic dialysis patients not affected by multiple myeloma
时间窗: 45 days
次要结局
- Compare beta 2 microglobulin removal by three different hemodialysis filters(45 days)
研究者
Gabriele Donati
M.D. Ph.D.
IRCCS Azienda Ospedaliero-Universitaria di Bologna