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临床试验/NCT06547697
NCT06547697已完成不适用

EFFECT OF DIFFERENT DIALYSATE SODIUM CONCENTRATIONS ON BLOOD PRESSURE IN CHRONIC HEMODIALYSIS PATIENTS

University Medical Centre Maribor0 个研究点目标入组 45 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
主要终点
Peridialytic blood pressure

研究概览

简要总结

While hypertension is one of the most common causes of end-stage renal disease, it is also present in the vast majority of hemodialysis patients. It is associated with higher cardiovascular morbidity and mortality in this group of patients. Altering dialysate sodium concentration presents a possibility of sodium balance control and blood pressure management. However, the ideal dialysate sodium concentration remains a topic for discussion.

Randomised and prospective single dialysis centre study is presented. The participants are randomly divided into 3 groups and will go through 3 periods of 2 months. A "low-to-high" dialysate sodium concentration group will start the study with 138 mmol/L in the first period, continue with 140 mmol/L in the second period and finish with 142 mmol/L. In the "high-to-low" group, the participants will go through the opposite design (reduction from 142 mmol/L to 138 mmol/L over 3 periods). One group will continue with 140 mmol/L throughout the study. Systolic and diastolic BP values before and after dialysis sessions, interdialytic weight gain, ultrafiltration, serum sodium concentration and the presence of hypotension between the groups in each period and within each group over all three periods will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • At least 18 years of age
  • Patients with end-stage renal disease hemodialysis for at least 3 months

排除标准

  • Non-cooperation
  • Active cancer
  • Hospitalization during the course of the study

结局指标

主要结局

Peridialytic blood pressure

时间窗: 6 months (3 periods of 2 months)

Pre- and post dialysis blood pressure values

次要结局

  • Interdialytic weight gain(6 months (3 periods of 2 months))
  • Ultrafiltration(6 months (3 periods of 2 months))
  • Serum sodium concentration(6 months (3 periods of 2 months))

研究者

发起方
University Medical Centre Maribor
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luka Varda

Assistant

University Medical Centre Maribor

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