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Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients

2011年10月24日 更新者:Lidiane Silva RodriguesTelini、UPECLIN HC FM Botucatu Unesp

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

详细说明

The prognosis of chronic kidney diseases (CKD) patients is strongly compromised by cardiovascular (CV) complications. Inflammation is established as a major risk factor for CV complications in these patients, occurring in approximately one third of them. Recently, growing evidences have suggested the body water volume expansion is a cause of inflammation in CKD. In a previous study Rodrigues Telini showed that dietary sodium restriction reduced the inflammatory markers levels in hemodialysis (HD) patients. Similar results were observed in patients treated by reduction of HD dialysate sodium concentration. However in both studies no significant reduction in body volume markers was observed. These results could be due to small number of patients or low sensibility of volume markers; on the other hand they could suggest a direct role of sodium as an inflammatory inducer independently of volume. With a larger number of patients and using a more sensitive volume marker as the B-type natriuretic peptide (BNP), this study intends to confirm the hypothesis that sodium mobilization can reduce the body water volume and attenuate the inflammatory in HD patients. A hundred thirty-five patients will be enrolled and divided in three groups with 35 patients: A, treated by reduction of 2 grams in daily sodium intake; B, exposed to reduction of sodium dialysate from 138 to 135 mEq/L and C, control group. The patients will be followed up by 16 weeks and inflammatory markers (CRP, interleukin-6, and tumor necrosis factor) as well as volume markers (Watson formula, electrical bioimpedance measurements and BNP concentration) will be determine each 8 weeks.

研究类型

介入性

注册 (实际的)

59

阶段

  • 第四阶段

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:
  • Dietary prescription
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:
  • Dialysis prescription
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

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年4月1日

初级完成 (实际的)

2009年2月1日

研究完成 (实际的)

2009年2月1日

研究注册日期

首次提交

2011年6月14日

首先提交符合 QC 标准的

2011年10月24日

首次发布 (估计)

2011年10月25日

研究记录更新

最后更新发布 (估计)

2011年10月25日

上次提交的符合 QC 标准的更新

2011年10月24日

最后验证

2011年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • upeclin/HC/FMB-Unesp-55

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Dietary sodium restriction的临床试验

3
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