Evaluation of Salt Status in Patients With Cystic Fibrosis

Completed

• Conditions: Cystic Fibrosis; Salt; Deficit (or Low)

• Registration Number: NCT04556162
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Primary Completion: 2021-11-21
• Study Completion: 2021-11-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• 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

Exclusion Criteria

• transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urinary sodium/urinary creatinin (mmol/mmol)	1 year	calculated based on urinary results
Fractional Potassium excretion (%)	1 year	= (serum creatinin X urinary Potassium)/(plasma PotassiumX urinary creatinin)
ratio urinary sodium/urinary potassium	1 year	= calculation of ration urinary sodium/potassium
Fractional Chloride excretion (percent)	1 year	= (serum creatinin X urinary Chloride)/(plasma Chloride X urinary creatinin)
fractional sodium excretion (percent)	1 year	= (serum creatinin X urinary Sodium)/(plasma sodiumX urinary creatinin)

Secondary Outcome Measures

Name	Time	Method
Body mass index	1 year	= Weight/Height X Height expressed as SD of the local population based on Flemish growth charts
Forced expiratory volume in 1 second	1 year	measured with lungfunction testing expressed as % of normal for height

Trial Locations

Locations (1)

Gent University Hospital; 🇧🇪 Gent, Belgium