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Completed

NCT Number: NCT04556162

Evaluation of Salt Status in Patients With Cystic Fibrosis

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.

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Key information

Conditions

Salt; Deficit (or Low) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Gent University Hospital

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fractional sodium excretion

Diagnostic Test

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

risk subgroups

Other

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

Primary outcomes

  1. fractional sodium excretion (percent)

    Time frame: 1 year

    = (serum creatinin X urinary Sodium)/(plasma sodiumX urinary creatinin)

  2. Urinary sodium/urinary creatinin (mmol/mmol)

    Time frame: 1 year

    calculated based on urinary results

  3. Fractional Chloride excretion (percent)

    Time frame: 1 year

    = (serum creatinin X urinary Chloride)/(plasma Chloride X urinary creatinin)

  4. Fractional Potassium excretion (%)

    Time frame: 1 year

    = (serum creatinin X urinary Potassium)/(plasma PotassiumX urinary creatinin)

  5. ratio urinary sodium/urinary potassium

    Time frame: 1 year

    = calculation of ration urinary sodium/potassium

Secondary outcomes

  1. Body mass index

    Time frame: 1 year

    = Weight/Height X Height expressed as SD of the local population based on Flemish growth charts

  2. Forced expiratory volume in 1 second

    Time frame: 1 year

    measured with lungfunction testing expressed as % of normal for height

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2020
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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