Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Rem
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Uremic Toxins Clearance
研究概览
简要总结
Conventional hemodialysis is essential for the treatment of ESRD patients by reducing serum concentration of uremic toxins and correcting fluid overload. Nevertheless, HD removes almost exclusively low-range uremic toxins. Convective methods might reduce complications associated to molecules of medium-range molecular weight. On-Line Hemodiafiltration (OL-HDF) is the result of the combination between convection and diffusion, this modality allows better clearence of middle-range molecules, and protein bound molecules with better hemodynamic tolerance, but at higher cost. In order to solve this problem the middle cut-off membranes were developed, achieving cleareance of molecules between 15,000 to 40,000 Da with low albumin loss. To our knowledge no study has ever evaluated the use of middle cut-off membranes on OL-HDF. This is a prospective, experimental study which will include 12 patients with ESRD that receive OL-HDF treatment on the National Institute of Cardiology "Ignacio Chavez" OL-HDF Unit. They will be divided in 4 groups: high flux HD, extended HD (HDx), OL-HDF, and OL-HDF with medium cut-off membrane.
详细描述
Introduction:
The Kidney Disease Improved Global Outcomes (KDIGO) defines Chronic Kidney Disease (CKD), as a decline of the glomerular filtration rate (GFR) below 60 mL/min/1.72 m2SC, associated with structural or functional abnormalities in a period greater than three months. CKD it's classified in 5 stages based con GFR and albuminuria . Stage 5 is considered the end stage, and it's also known as End Stage Renal Disease (ESRD), in this stage usually the patients require some kind of renal function replacement (RFR), otherwise CKD will cause the death of the patient.
In Mexico the principal cause of CKD is Type 2 Diabetes Mellitus (DM2), closely followed by Systemic Arterial Hypertension (SAH), according to the 2012 National Survey of Health and Nutrition (ENSANUT) from Mexico there are 6.4 million adults with DM2, and 22.4 million adults with SAH. In Mexico the prevalence of patients currently receiving RFR it's unknown, but based in different sources we estimate that 129 thousand patients have ESRD, and only 60 thousand receive some kind of RFR therapy.
In Mexico (based on data published by the Mexican Institute of Social Security), 41% of the dialysis patients are on hemodialysis (HD). ESRD patients on HD have a greater incidence of cardiovascular outcomes which cause an important impact on survival. This increase on cardiovascular outcomes can be explained by the high prevalence in this population of type 2 diabetes mellitus, and hypertension, as well as adverse outcomes associated with uremia such as chronic inflammation, and bone mineral disease vascular calcifications.
Uremic toxins are clasiffied according to their molecular weight in low-range molecules (< 500 Da), middle-range molecules (500 Da - 60 kDa), hydrosoluble molecules, and protein bound molecules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Age greater or equal to 18 years.
- •Patients that receive OL-HDF three times per week.
- •Patients with no residual uresis.
- •Hemoglobin greater that 7 g/L.
- •Patients that can exercise during treatment.
- •Patients must sign informed consent.
排除标准
- •Age less tan
- •Presence of residual uresis.
- •Hb less that 7 g/L.
- •Patients incapable of exercising during dialysis.
结局指标
主要结局
Uremic Toxins Clearance
时间窗: 1 month
The combination of On Line Hemodiafiltration with an MCO membrane will have a better sieving coefficient for middle and protein bound molecules in comparison with other dialysis modalities.
次要结局
未报告次要终点
研究者
Magdalena Madero
Head of Nephrology
Instituto Nacional de Cardiologia Ignacio Chavez