Evaluation of Salt Status in Patients With Cystic Fibrosis and the Influence on Nutritional Status and Pulmonary Function. Looking for the Best Surrogate Urinary Markers for Fractional Sodium or Chloride Excretion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Urinary sodium/urinary creatinin (mmol/mmol)
研究概览
简要总结
The results of the annual check-up will be collected to evaluate the best urinary marker for fractional sodium excretion and salt status will be correlated to clinical outcome measures.
详细描述
Patients with cystic fibrosis need extra salt as they have increased losses through sweat. Current advices are to follow and supplement if needed, however the way to follow salt depletion is unclear.
The best way is to calculate fractional salt excretion. This needs a simultaneous blood and urine sample for electrolytes and creatinin. Urinary surrogate markers have been validated on only 10 patients.
At the annual check-up patients with cystic fibrosis receive these measurements. The investigators will collect the measurements and calculate fractional excretion and the possible surrogate markers on urine. Further this will be correlated to nutritional and pulmonary status and patient subgroups at risk will be identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all cystic fibrosis patients followed at the Gent University Cystic fibrosis centre
- •Providing a paired urine and blood sample at the time of their annual check-up
排除标准
- •transplantation
结局指标
主要结局
Urinary sodium/urinary creatinin (mmol/mmol)
时间窗: 1 year
calculated based on urinary results
Fractional Chloride excretion (percent)
时间窗: 1 year
= (serum creatinin X urinary Chloride)/(plasma Chloride X urinary creatinin)
Fractional Potassium excretion (%)
时间窗: 1 year
= (serum creatinin X urinary Potassium)/(plasma PotassiumX urinary creatinin)
ratio urinary sodium/urinary potassium
时间窗: 1 year
= calculation of ration urinary sodium/potassium
fractional sodium excretion (percent)
时间窗: 1 year
= (serum creatinin X urinary Sodium)/(plasma sodiumX urinary creatinin)
次要结局
- Body mass index(1 year)
- Forced expiratory volume in 1 second(1 year)