NCT04556162

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
• Phase: —
• Study type: Observational
• Enrollment: 222 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Salt; Deficit (or Low)
• Cystic Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	fractional sodium excretion	fractional sodium excretion will be compared to urinary sodium/creatinin, sodium/potassium ratio's and sodium concentration.
OTHER	risk subgroups	subgroup analysis will be performed to identify the patient groups at risk for sodium depletion

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-11-21
• Completion: 2021-11-21
• First posted: 2020-09-21
• Last updated: 2022-12-01

Locations

1 site across 1 country: Belgium