The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood pressure during the hemodialysis
研究概览
简要总结
Background:
Patients with decreased kidney function are in the positive acid balance due to insufficient renal acid excretion. To correct the varying degrees of metabolic acidosis in these HD patients, a high concentration of HCO3 in the dialysate is routinely used.
During every 3-to-4 hours of HD treatment, a massive surge of HCO3 would enter the circulation and typically overcorrects predialysis acidosis to alkalosis and alkalemia.
The sharp acid-base shift can cause some adverse consequences.
The investigators believe that the rapid correction (or overcorrection) from the pre-dialysis metabolic acidosis to post-dialysis metabolic alkalosis during the 3-to-4 hours HD treatment would relate to adverse effects on HD patients.
Thus the investigators conduct this study to prove the hypothesis that "prevention of post-dialysis alkalosis by using lower dialysate HCO3 concentration might cause less adverse outcomes in ESRD patients on HD."
Study design:
Prospective cross-over case-control study.
Study population:
A total of 60 patients who receive regular hemodialysis (three times per week) for more than 6 months in the regional teaching hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult uremic patients who received hemodialysis thrice weekly
排除标准
- •Hospitalized patients
- •Patients newly initiated on HD (<6 months)
- •Patients with HD access problems
- •Patients recently discharged from the hospital (within one month).
- •Patients on chemotherapy for cancer.
- •Patients with a kidney transplant.
- •Patients on steroids or other immunosuppressive therapy.
- •Patients with recent surgery (within one month)
- •Patients with an active bacterial infection.
- •Patients with decompensated cirrhosis.
研究组 & 干预措施
Intervention-Control group
In this group, the participants will receive "intervention" for 2 months first, followed by a wash-out period of 1 month and "control" for 2 months.
In the "intervention period," the investigators will provide the participants with lower dialysate HCO3 concentrations. (dialysate HCO3 to 28 mmol/L for half of the HD session and 30 to the second half of their HD session.) Besides, the investigators will give the participants with pre-HD HCO3<22 mEq/L oral Na-bicarbonate 650 mg 1#-2# three times a day as supplements.
In the "control period," the investigators will provide the participants with dialysate HCO3 concentration of 38-40 mEq/L (as we usually provide to patients).
干预措施: Concentration of dialysate bicarbonate (Procedure)
Control-Intervention group
In this group, the participants will receive "control" for 2 months first, followed by a wash-out period of 1 month and "intervention" for 2 months.
In the "control period," the investigators will provide the participants with dialysate HCO3 concentration of 38-40 mEq/L (as we usually provide to patients).
In the "intervention period," the investigators will provide the participants with lower dialysate HCO3 concentrations. (dialysate HCO3 to 28 mmol/L for half of the HD session and 30 to the second half of their HD session.) Besides, the investigators will give the participants with pre-HD HCO3<22 mEq/L oral Na-bicarbonate 650 mg 1#-2# three times a day as supplements.
干预措施: Concentration of dialysate bicarbonate (Procedure)
结局指标
主要结局
Blood pressure during the hemodialysis
时间窗: four months
Blood pressure will be measured every 1 hour during the hemodialysis
O2 saturation during the hemodialysis
时间窗: four months
O2 saturation will be measured every 1 hour during the hemodialysis
Respiratory rate during the hemodialysis
时间窗: four months
Respiratory rate will be measured every 1 hour during the hemodialysis
次要结局
未报告次要终点
研究者
Chih-Chung Shiao, MD
Director, Dept. of Medical Research and Education, Saint Mary's Hospital Luodong
Camillians Saint Mary's Hospital Luodong