The Development and Validation of a Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- determination coefficient of the novel equation
研究概览
简要总结
This study aims to develop a novel equation for estimating sodium intake in anuric peritoneal dialysis patients, and then to validate its precision and accuracy.
详细描述
Dietary sodium intake is closely associated with the prognosis of chronic kidney disease (CKD) patients. Previous studies have developed an equation for estimating dietary sodium intake through 24-hour urine sodium in CKD, which are not applicable in peritoneal dialysis patients. This study aims to develop a novel equation for estimating dietary sodium intake in 20 anuric peritoneal dialysis patients, using accurately measured dietary sodium as the dependent variable and peritoneal sodium removal and its related variables as independent variables, and then to validate the precision and accuracy of the novel equation in another 10 anuric peritoneal dialysis patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peritoneal dialysis vintage >3 months.
- •18-80 years old.
- •No residual renal function (urine volume<200ml/day).
排除标准
- •Peritonitis in the past month.
- •Acute systemic infection, cardio-cerebrovascular complications and surgical trauma in the past month.
- •Uncorrected hyponatremia (blood sodium<130mmol/L).
- •Prescribed with sodium bicarbonate.
- •Prescribed with glucocorticoids and aldosterone antagonists.
- •Dysfunction of peritoneal dialysis catheter.
- •Malignant tumor receiving radiotherapy and chemotherapy, severe dyspepsia or eating disorder.
- •Body fluid loss due to vomit, diarrhea, massive sweating, or other causes.
- •Cannot follow the research scheme.
- •Refuse to participate in this study.
结局指标
主要结局
determination coefficient of the novel equation
时间窗: July 3, 2023, to March 1, 2024
Determination coefficient will be assessed as the square of the multiple correlation coefficient of the novel equation for estimating sodium intake in peritoneal dialysis.
bias of the novel equation
时间窗: July 3, 2023, to March 1, 2024
Bias will be assessed as the median of the difference between the estimated and measured dietary sodium values.
precision of the novel equation
时间窗: July 3, 2023, to March 1, 2024
Precision will be assessed as the standard deviation (SD) for the absolute value of difference between the estimated and measured dietary sodium values.
accuracy of the novel equation
时间窗: July 3, 2023, to March 1, 2024
Accuracy will be assessed as the percentage of estimates that differed \>20% from the measured dietary sodium values (1-P20) .
次要结局
未报告次要终点
研究者
Dong Jie
Director of PD center
Peking University First Hospital