Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Intradialytic hemodynamic stability
研究概览
简要总结
The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Informed consent signed and dated by study patient and authorized physician
- •Minimum age of 18 years
- •The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial
- •Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on dialysis as extracorporeal renal replacement therapy.
- •Study-specific:
- •Patients on dialysis (HD/HDF), at least 4h treatment time thrice weekly ≥ 3 months using a standard dialysate with a prescribed sodium concentration of 136 mmol/L
- •Anuric patients (<300mL/d; 1 measurement within last 4 weeks)
- •Patient fulfils one of the four following criteria:
- •interdialytic weight gain over 4% of dry weight (mean value during run-in period) OR pre-dialytic systolic blood pressure over 180 mmHg (mean value during run-in period) OR intradialytic morbid events (hypotension, hypertension, cramps, headache) in at least three sessions during run-in period OR volume overload according to BCM (FO ≥2.5 L pre-dialysis or relative FO pre-dialysis ≥15% for men and ≥13% for women; one measurement during run-in period)
- •- Patients with a diffusive Na load of at least 1 mmoL/(L TBW) or 0.06g NaCl/(L TBW) (mean value during the run-in period).
排除标准
- •Any conditions which could interfere with the patient's ability to comply with the study
- •Patient is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- •In case of female patients: pregnancy (pregnancy test will be conducted at start and end of study with female patients aged ≤55 years) or lactation period
- •Participation in an interventional clinical study during the preceding 30 days
- •Previous participation in the same study
- •Study-specific:
- •Patients treated with individualized sodium management over the last 3 months
- •Severe hypoalbuminemia (≤30 g/L; 1 measurement within last 4 weeks)
- •Hypernatremia (pre-dialytic plasma sodium concentration ≥145mmol/L; 1 measurement within last 4 weeks)
- •Uncontrolled diabetic patients with glycated hemoglobin (HbA1C) >8%; 1 measurement within last 4 weeks
- •Impossible reliable measurement of the different compartments by bioimpedance due to lower limb amputation or wearing of a unipolar pacemaker or metallic prostheses
- •Life expectancy less than 6 months
- •ONLINEplus HF treatments/hemofiltration treatments
- •Single-needle treatments
- •Dry weight < 40kg
- •Active or chronic infections (HIV, SARS-CoV-2, HBV, HCV)
结局指标
主要结局
Intradialytic hemodynamic stability
时间窗: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on intradialytic hemodynamic stability will be analyzed based on frequency of intradialytic hypotensive episodes
Interdialytic weight gain
时间窗: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on interdialytic weight gain will be analyzed in kg and % of dry weight
Intradialytic morbid events
时间窗: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on the frequency of intradialytic morbid events will be analyzed
Fluid status
时间窗: 12 weeks after start of study
Evaluation of the impact of sodium zero-diffusive dialysis on fluid status will be analyzed with regard to overhydration (L)
次要结局
- PRO: HRQOL(12 weeks after start of study)
- PRO: Hypotensive episodes(12 weeks after start of study)
- PRO: Health status(12 weeks after start of study)
- PRO: Fatigue(12 weeks after start of study)
- PRO: Thirst feeling(12 weeks after start of study)