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临床试验/NCT02792530
NCT02792530Unknown不适用

Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

Rabin Medical Center0 个研究点目标入组 20 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Reduction in intradialytic weight gain (IDWG)

研究概览

简要总结

This study will evaluate the efficiency of dietary intervention on intradialytic weight gain. Uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5 kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for sodium restriction. One month after the intervention, their intradialytic weight accumulation will be measured.

详细描述

Inter Dialytic Weight Gain (IDWG) ascribed to fluid retention is one of the major clinical problem that patients in hemodialysis need to cope with between 2 subsequent hemodialysis especially in patients with no residual renal function. Fluid retention is associated with morbid conditions such as lower-extremity edema, ascites, pulmonary vascular congestion or edema, hypertension, and worsening heart failure. Gain weight above 2 kg between 2 subsequent hemodialysis found to be in higher risk of all-cause mortality and cardiovascular death .Lowering daily sodium intake found to mitigate fluid retention ,however there are only a few researches that check it. 2IDWG also associated with poorer quality of life. Dietary sodium restriction recommendation since the beginning of hemodialysis are based on association of this restriction with balance of hypertension and fluid retention. Sodium intake recommended for patients in hemodialysis is limited to 2 grams a day. Nevertheless, there are only a few studies that examine the efficiency of this restriction because of the complexity of measurement of sodium intake. One recently published study which used a 24-h recall to measure sodium intake, found a direct correlation between IDGW and mortality form any reason. In spite of this complexity, IDWG has been found to be in a direct relation with patients' nutrition status.

One of sodium-related issues is malnutrition. Malnutrition in dialysis is a risk factor for patients' morbidity and mortality. Higher sodium intake is associated with higher calorie and protein intake, while adherence to restriction of sodium intake is poor in hemodialysis. This is a reason for high importance to study effects of sodium restriction in people with more than 2.5 kg (or 4% of dry body weight) IDWG while following up their nutritional status

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Adults >18 years providing signed informed consent.
  • Any patient more than 3 months in hemodialysis who reach his assigned dry weight.
  • Intradialytic weight gain of more than 2.5 liters or 4% of dry body weight in two mid-week sessions.
  • residual renal function of less than 200 ml per 24 hr.
  • expected to stay on hemodialysis for at least 6 month.

排除标准

  • Malnutrition as assessed by SGA: score C.
  • Active malignancy
  • Active infection

结局指标

主要结局

Reduction in intradialytic weight gain (IDWG)

时间窗: between baseline and 6 weeks

Reduction in the weight gain at 2 subsequent hemodialysis in KG/

次要结局

  • Changes in quality of life(between baseline and 6 weeks)
  • number of hypotensive episode during dialysis(at baseline and 6 weeks)
  • Changes in subjective global assesment (SGA)(between baseline and 6 weeks)
  • dietary sodium intake.(at baseline and 6 weeks)
  • Change in CRP values(between baseline and 6 weeks)
  • change in predialysis blood pressure(between baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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