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临床试验/NCT02519894
NCT02519894Unknown不适用

Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease

PANTHITA SORNHIRAN0 个研究点目标入组 600 人开始时间: 2015年8月最近更新:
适应症

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

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

发起方
PANTHITA SORNHIRAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

PANTHITA SORNHIRAN

PANTHITA SORNHIRAN

Ramathibodi Hospital

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