NCT07765459已完成1 期
The Effect of Interdialytic Serum Bicarbonate Correction on Vascular Calcification in Prevalent Hemodialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- correction of acidosis and its effect on vascular calcification
研究概览
简要总结
the investigators will test the effect of interdialytic metabolic acidosis correction on vascular calcification in hemodialysis patients
详细描述
- Type of Study: Prospective randomized interventional study using simple randomization ( even and odd number method )
- Study Settings: Ain Shams University hospital hemodialysis unit , Cairo, Egypt.
- Study period: 6 months.
Inclusion Criteria:
- Adult prevalent hemodialysis patients on regular hemodialysis more than 6 months , three sessions per week of four hours duration
- Patients with metabolic acidosis at the time they were recruited with serum bicarbonate levels ≤22 mmol/l for at least 6 months before the study.
Exclusion Criteria: patients with the following will be excluded from the study
- Patients with hemodialysis catheters
- Patients with active inflammation , infection or active malignancy
- Patients with history of parathyroidectomy
- Patients with other organ failure such as decompensated heart failure or liver cell failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Adult prevalent hemodialysis patients (age 18 years or older) On regular hemodialysis for more than 6 months, with three sessions per week, each lasting four hours Metabolic acidosis at the time of recruitment, defined as a serum bicarbonate level ≤22 mmol/L for at least 6 months before the study
排除标准
- •Patients with hemodialysis catheters Active inflammation, infection, or active malignancy History of parathyroidectomy Other organ failure, such as decompensated heart failure or liver failure
研究组 & 干预措施
oral sodium bicarbonate
Active Comparator
this group will receive oral sodium bicabonate daily
干预措施: Oral sodium bicarbonate (Drug)
no intervention : control group
No Intervention
participants in this arm will receive standard care without bicarbonate supplementation : they will serve as the control group for comparison
结局指标
主要结局
correction of acidosis and its effect on vascular calcification
时间窗: 6 months
change in carotid intimal media thickness (CIMT ) , measured by B mode ultrasound of the common carotid artery , the unit is millimeters
次要结局
- Change in Serum Calcium Level(6 months)
- Change in Serum Phosphorus Level(6 months)
- Change in Intact Parathyroid Hormone (iPTH) Level(6 months)
- Change in Hemoglobin Concentration(6 months)
- Change in Serum Albumin Level(Unit of Measure: g/dL)
- Change in Venous Blood pH(6 months)
- Change in Serum Bicarbonate Level(6 months)
研究者
研究点 (1)
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