Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Malnutrition-inflammation score (MIS)
研究概览
简要总结
In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.
详细描述
The study is designed as a single-center, prospective, observational research. A total of 50 stable-course chronic hemodialysis patients over 18 years of age and treated for at least 3 months will be included in the study and the study period will be planned for 12 months. 25 of the 50 chronic hemodialysis patients planned to be included in the study will use MCO-membrane and the other 25 will use high-flux membrane. The distribution of patients to the high-flux membrane and MCO membrane groups will be done randomly (sequentially single-pair number method). Then, the standard 12-hour (3x4 hours/week) hemodialysis treatment will continue. At the beginning of the study (0.), at the end of the third (3.) month and at the end of the sixth (6.) month;
Monthly laboratory tests routinely performed on hemodialysis patients (tests routinely performed in hemodialysis patient follow-up) 5 ml blood samples will be taken from the hemodialysis set to determine the levels of medium-large molecule-weight toxins-wastes and inflammatory parameters before and after dialysis, and the sera will be separated and stored at -80oC for use at the end of the study.
Automatic blood pressure measurement will be performed before and after hemodialysis to evaluate arterial stiffness.
The Malnutrition Inflammation Score will be applied to evaluate the nutritional status (the MIS form is given in the appendix) Visual Analog Scale will be used for appetite Visual Analog Scale will be used for uremic pruritus Depression scale screening (Beck's scale)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients continuing the hemodialysis program for at least 3 months
- •Patients over 18 years of age
排除标准
- •Patients with advanced heart failure, malignancy, terminal illness
- •Patients with active infectious disease
- •Acute hemodialysis patients
- •Patients vascular access dysfunction
结局指标
主要结局
Malnutrition-inflammation score (MIS)
时间窗: At the end of the 6th month after randomization.
The malnutrition-inflammation score will be recorded at the conclusion of the study. This score ranges from 0 to 30, with higher scores indicating worse outcomes.
Erythropoietin Doses
时间窗: September 2020
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Phosphorus levels control
时间窗: September 2020
Serum phosphorus levels will be tested on a monthly basis.
Parathyroid hormone levels control
时间窗: September 2020
Serum parathyroid hormone levels will be tested on a monthly basis.
Depressive disorder
时间窗: At the end of the 6th month after randomization.
At the conclusion of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.
Hemoglobin
时间窗: September 2020
Hemoglobin levels will be measured on a monthly basis.
Uremic pruritus
时间窗: At the end of the 6th month after randomization.
At the conclusion of the study, the visual analog scale for pruritus will be recorded. This score ranges from 0 to 10, with higher scores indicating worse itching.
Restless leg syndrome
时间窗: At the end of the 6th month after randomization.
At the conclusion of the study, the Restless Leg Syndrome screening questionnaire will be administered. This score ranges from 0 to 40, with higher scores indicating worse symptoms.
Appetite
时间窗: At the end of the 6th month after randomization.
At the conclusion of the study, the visual analog scale of appetite will be recorded. This score ranges from 0 to 5, with higher scores indicating better appetite.
次要结局
未报告次要终点
研究者
Tuncay Sahutoglu
Associate Professor
Sanliurfa Mehmet Akif Inan Education and Research Hospital