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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Salt; Deficit (or Low)
• Intervention / Treatment: Diagnostic test: fractional sodium excretion; Other: risk subgroups

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 Type: Observational
• Enrollment (Actual): 222

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Gent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All cystic fibrosis patients for whom a complete analysis of both blood and urine is available at the time of their annual check-up

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Stephanie Van Biervliet, MD, PhD, Gent University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): November 21, 2021
• Study Completion (Actual): November 21, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: BC-05673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No