Skip to content

Evaluation of Salt Status in Patients With Cystic Fibrosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04556162
Enrollment
222
Registered
2020-09-21
Start date
2018-01-01
Completion date
2021-11-21
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Salt; Deficit (or Low)

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.

Interventions

DIAGNOSTIC_TESTfractional sodium excretion

fractional sodium excretion will be compared to urinary sodium/creatinin, sodium/potassium ratio's and sodium concentration.

OTHERrisk subgroups

subgroup analysis will be performed to identify the patient groups at risk for sodium depletion

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary sodium/urinary creatinin (mmol/mmol)1 yearcalculated based on urinary results
Fractional Potassium excretion (%)1 year= (serum creatinin X urinary Potassium)/(plasma PotassiumX urinary creatinin)
ratio urinary sodium/urinary potassium1 year= calculation of ration urinary sodium/potassium
fractional sodium excretion (percent)1 year= (serum creatinin X urinary Sodium)/(plasma sodiumX urinary creatinin)
Fractional Chloride excretion (percent)1 year= (serum creatinin X urinary Chloride)/(plasma Chloride X urinary creatinin)

Secondary

MeasureTime frameDescription
Forced expiratory volume in 1 second1 yearmeasured with lungfunction testing expressed as % of normal for height
Body mass index1 year= Weight/Height X Height expressed as SD of the local population based on Flemish growth charts

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026