Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 主要终点
- The declination of glomerular infiltration rate
研究概览
简要总结
Introduction :
Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. One of the problem in sodium restriction failure in Thai population with CKD nowadays is lack of knowledge and problem unawareness.
The study hypothesis :
Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR reduction rate
Objectives :
To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between CKD patients receiving strict controlled combined with immediate individual feedback (DISC Progrram) and those receiving standard education.
Study design :
Multicenter, open labeled, parallel, randomized controlled trial
Sample size : 600
Primary outcome : GFR reduction (CKD-EPI)
Secondary outcome :
- Achievement rate of Na intake < 2 g/day (Urine Na < 90 mEq/day)
- Blood pressure difference
- Proportions of patients with BP reached the target (130/80 mmHg)
- Number of anti-hypertensive drugs use to achieve BP target
- Urine albumin/creatinine ratio
- Major Adverse Cardiac Events (MACE)
- Cardio-ankle vascular index (CAVI)
- ankle-brachial index (ABI)
Documentary Proof of Ethical Clearance :
This project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²)
- •Microalbuminuria
- •Any blood pressure level
排除标准
- •Salt - losing conditions
- •Hyponatremia (Na < 135 mg/dL) or Hypernatremia (Na > 145 mg/dL)
- •Bilateral renal artery stenosis
- •Severe comorbid disease or life expectancy <1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy)
- •Immunosuppressant used
结局指标
主要结局
The declination of glomerular infiltration rate
时间窗: one year
次要结局
未报告次要终点
研究者
PANTHITA SORNHIRAN
PANTHITA SORNHIRAN
Ramathibodi Hospital
