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
NCT number | NCT04556162 |
Other study ID # | BC-05673 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | November 21, 2021 |
Verified date | November 2022 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Gent University Hospital | Gent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
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 |
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