Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients
Effects of Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients. A Prospective Randomized Controlled Study
Objective: To evaluate the influence of dietary sodium reduction on body fluid volume and inflammatory state in hemodialysis (HD) patients.
Design: Prospective controlled randomized study. Setting: Dialysis Unit of Botucatu Medical School Hospital, Sao Paulo State University, Brazil.
Patients: Adult patients on HD for at least 30 days and C-reactive protein (CRP) ≥ 0.7 mg/dl were randomly allocated into two groups: Group A: 21 patients treated with a 2g sodium restriction in their habitual diet, and Group B: 18 controls. Inflammatory, biochemical, hematological and nutritional markers, as well as dialysis dosage were assessed at baseline and after 8 and 16 weeks.
研究概览
地位
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- included patients aged ≥ 18 years who had been on hemodialysis for at least 90 days, and were diagnosed with inflammation. Inflammation was defined as C Reactive Protein ≥ 0.7 mg/dL
Exclusion Criteria:
- acute inflammatory processes confirmed by clinical criteria and/or complementary tests
- acute inflammatory diseases
- tuberculosis
- use of antibiotics within the past two months
- chronic inflammatory diseases
- neoplasias
- chronic obstructive pulmonary disease
- use of central venous catheter and positive HIV serology
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Group A
Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet.
|
Restriction of 2 grams on daily sodium diet intake.
其他名称:
|
实验性的:Group B
Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L
|
Reduction of dialysate sodium concentration from 138 to 135 mEq/L
其他名称:
|
无干预:Group C
Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
C-reactive protein
大体时间:up to 16 weeks
|
The outcome will be evaluates each eight weeks
|
up to 16 weeks
|
interleukin-6
大体时间:up to 16 weeks
|
The outcome will be evaluates each eight weeks
|
up to 16 weeks
|
alpha tumor necrosis serum concetrations
大体时间:up to 16 weeks
|
The outcome will be evaluates each eight weeks
|
up to 16 weeks
|
合作者和调查者
调查人员
- 首席研究员:Lidiane R. Telini, MSC、UPECLIN HC FM Botucatu Unesp
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Dietary sodium restriction的临床试验
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