Effect of Sodium Concentration of Priming and Rinsing Fluids on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients: a Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Interdialytic weight gain
研究概览
简要总结
Sodium loading during hemodialysis treatment is common and may contribute to increased interdialytic weight gain and hypertension. Excessive use of isotonic saline (containing 0.9% sodium chloride) is one of the factors that may cause sodium loading. During each hemodialysis session, approximately 400 mL of isotonic saline fluid, representing 1.4 grams of sodium, is used to prime and rinse the extracorporeal circuit, and is often administered to the patient. Switching to a non sodium-containing priming and rinsing fluid could allow for removal of the equivalent amount of sodium.
Switching to a non sodium-containing solution for the priming and rinsing of the extracorporeal circuit can contribute to increased sodium removal during the dialysis treatment and allow for reduced interdialytic weight gain, reduced thirst, and improved blood pressure control.
详细描述
This 12 week study consists of 3 phases:
Phase 1 (4 weeks): Observation only. Standard priming/rinsing procedure with isotonic saline Phase 2 (4 weeks): Intervention. Switch to a 5% dextrose solution for priming/rinsing procedure Phase 3 (4 weeks): Switch back to standard priming/rinsing procedure with isotonic saline During the study, blood pressures will be measured in a standardized manner at 2 week intervals, a thirst questionnaire will be completed at the end of each phase, and interdialytic weight gain, in-center pre/post-HD blood pressure and intradialytic symptoms will be recorded, apart for routinely measured parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regimen.
- •Willing and able to provide written, signed informed consent after the nature of the study has been explained.
- •Willing and able to comply with all study procedures.
- •Age ≥18 years.
排除标准
- •Diabetes mellitus
- •Considerable residual renal function (diuresis > 500 mL/day)
- •Simultaneous participation in another clinical study except observational trials
- •Any psychological condition which could interfere with the patient's ability to comply with the study protocol
- •Expectation that native kidney function will recover
- •Impossibility to perform a blood pressure measurement on the upper limb
- •Unable to verbally communicate in English
- •Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period.
- •Life expectancy < 6 months
结局指标
主要结局
Interdialytic weight gain
时间窗: 12 weeks
次要结局
- Intradialytic events.(12 weeks)
- Thirst levels(12 weeks)
- Pre and post dialysis blood pressure levels.(12 weeks)