Toxins Removal and Inflammatory State modulAtion During Online Hemodiafiltration: Comparison of Two Different Dialyzers
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Measurement of uremic toxins
研究概览
简要总结
The primary goal of the study is to evaluate in patients on three times a week on-line HDF the efficacy, in terms of toxin removal and modulation of the inflammatory state, of two different dialyzers: Helixone versus Asimmetric cellulose triacetate (ATA).
详细描述
Patients with end-stage renal disease (ESRD) have a significantly increased cardiovascular mortality rate compared to the general population.
According to the USRDS (United States Renal Data System), in 2017 the prevalence of cardiovascular disease in the United States was 65.8% in patients with chronic kidney disease (CKD), compared to 31.9% of the subjects with stable renal function (https://www.usrds.org/2017/view/v1_04.aspx).
In the natural history of nephropathy, besides the traditional cardiovascular risk factors, an increasingly important role is played by the nontraditional factors related to uremia and dialysis treatment, namely anemia, hyperhomocysteinemia, malnutrition, hyperparathyroidism, electrolyte imbalance, and above all chronic inflammatory state and oxidative stress. The main components of dialysis-related inflammatory response include neutrophil and monocyte activation, cytokine release, oxidative stress with production of free radicals, lipid and protein oxidation, and alterations in blood redox state.
There is much evidence to indicate that ESRD patients, especially those on dialysis, are exposed to increased oxidative and carbonyl stress, that cause chemical modifications of proteins and accumulation of AGEs (advanced glycation end products).
The formation of AGEs occurs through Maillard reaction, a non-enzymatic glycation of peptide amino groups, resulting in protein structural and functional alteration and production of reactive carbonyl species .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients with chronic renal failure under periodic standard bicarbonate hemodialysis;
- •Three times a week dialysis session;
- •Residual diuresis <200 mL/day;
- •Age >18 years;
- •Vascular access for hemodialysis with blood flow >250 mL/minute;
- •Need of on-line hemodiafiltration (HDF) for signs of middle molecules intoxication (e.g. B2M >30 mg/L, peripheral neuropathy, cardiovascular comorbidities) or for intradialytic hypotension.
排除标准
- •Acute coronary syndrome;
- •Acute hemorrage;
- •Enrollment in another study protocol;
- •Active infection;
- •Malignancy;
- •Inability to provide written signed consent to participate in the study.
结局指标
主要结局
Measurement of uremic toxins
时间窗: 24 months. Blood samples will be drawn at Time 0 (on starting the study when the patients starts HDF treatment), after 1 month, after 3 months, after 6 months, after 12 months, and after 24 months (study end)
Beta 2 microglobulin (B2M), C-reactive protein (CRP), albumin, myoglobin, light chains, retinol binding protein, homocysteine, p-cresol, indoxyl sulfate, BPA, alpha-2-macroglobulin (A2M), FGF23 (fibroblast growth factor 23)
次要结局
- Measurement of endothelial cells metabolism(24 months. Blood samples will be drawn at Time 0 (on starting the study when the patients starts HDF treatment), after 1 month, after 3 months, after 6 months, after 12 months, and after 24 months (study end))
- Patients survival(24 months)
- Body impedance analysis(24 months.)
- AGEs measurements(24 months)
- Measurement of inflammatory cytokines(24 months. Blood samples will be drawn at Time 0 (on starting the study when the patients starts HDF treatment), after 1 month, after 3 months, after 6 months, after 12 months, and after 24 months (study end))
- Measurement of inflammatory cell activation(24 months. Blood samples will be drawn at Time 0 (on starting the study when the patients starts HDF treatment), after 1 month, after 3 months, after 6 months, after 12 months, and after 24 months (study end))
- Infection rate(24 months)
- Cardiovascular diseases(24 months)
研究者
Gabriele Donati
Principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna