Evaluation of Salt Status in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556162
• Other study ID #: BC-05673
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: November 21, 2021

Study information

• Verified date: November 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: November 21, 2021
• Est. primary completion date: November 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Belgium	Gent University Hospital	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fractional sodium excretion (percent)	= (serum creatinin X urinary Sodium)/(plasma sodiumX urinary creatinin)	1 year
Primary	Urinary sodium/urinary creatinin (mmol/mmol)	calculated based on urinary results	1 year
Primary	Fractional Chloride excretion (percent)	= (serum creatinin X urinary Chloride)/(plasma Chloride X urinary creatinin)	1 year
Primary	Fractional Potassium excretion (%)	= (serum creatinin X urinary Potassium)/(plasma PotassiumX urinary creatinin)	1 year
Primary	ratio urinary sodium/urinary potassium	= calculation of ration urinary sodium/potassium	1 year
Secondary	Body mass index	= Weight/Height X Height expressed as SD of the local population based on Flemish growth charts	1 year
Secondary	Forced expiratory volume in 1 second	measured with lungfunction testing expressed as % of normal for height	1 year