Salt; Deficit (or Low)NCT04556162
Evaluation of Salt Status in Patients With Cystic Fibrosis
An observational study of Salt; Deficit (or Low) and Cystic Fibrosis, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Salt; Deficit (or Low), Cystic Fibrosis
- What is being tested?
- fractional sodium excretion and risk subgroups
- How many people
- 222 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2018to 21 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- transplantation
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- fractional sodium excretion, risk subgroups
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional sodium excretionDiagnostic test
fractional sodium excretion will be compared to urinary sodium/creatinin, sodium/potassium ratio's and sodium concentration.
risk subgroupsOther
subgroup analysis will be performed to identify the patient groups at risk for sodium depletion
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional sodium excretion (percent)
= (serum creatinin X urinary Sodium)/(plasma sodiumX urinary creatinin)
Measured: 1 year
Urinary sodium/urinary creatinin (mmol/mmol)
calculated based on urinary results
Measured: 1 year
Fractional Chloride excretion (percent)
= (serum creatinin X urinary Chloride)/(plasma Chloride X urinary creatinin)
Measured: 1 year
Fractional Potassium excretion (%)
= (serum creatinin X urinary Potassium)/(plasma PotassiumX urinary creatinin)
Measured: 1 year
ratio urinary sodium/urinary potassium
= calculation of ration urinary sodium/potassium
Measured: 1 year
Secondary outcomes (2)
Body mass index
= Weight/Height X Height expressed as SD of the local population based on Flemish growth charts
Measured: 1 year
Forced expiratory volume in 1 second
measured with lungfunction testing expressed as % of normal for height
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Jan 2018
- Primary completion21 Nov 2021
- Study completion21 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salt; Deficit (or Low)Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Van Biervliet, MD, PhD, Principal investigator, Gent University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556162
- Sponsor's protocol ID
- BC-05673
- Status last verified
- Nov 2022
- First submitted
- 19 Aug 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04556162
- Acronym / sponsor ID
- BC-05673
- Conditions
- Salt; Deficit (or Low), Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 21 Nov 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractional sodium excretionfractional sodium excretion will be compared to urinary sodium/creatinin, sodium/potassium ratio's and sodium concentration. | Diagnostic test | – |
| risk subgroupssubgroup analysis will be performed to identify the patient groups at risk for sodium depletion | Other | – |
Primary outcome
fractional sodium excretion (percent)
Time frame: 1 year
= (serum creatinin X urinary Sodium)/(plasma sodiumX urinary creatinin)
Urinary sodium/urinary creatinin (mmol/mmol)
Time frame: 1 year
calculated based on urinary results
Fractional Chloride excretion (percent)
Time frame: 1 year
= (serum creatinin X urinary Chloride)/(plasma Chloride X urinary creatinin)
Fractional Potassium excretion (%)
Time frame: 1 year
= (serum creatinin X urinary Potassium)/(plasma PotassiumX urinary creatinin)
ratio urinary sodium/urinary potassium
Time frame: 1 year
= calculation of ration urinary sodium/potassium
2 secondary outcomes
Body mass index
Time frame: 1 year
Forced expiratory volume in 1 second
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Van Biervliet, MD, PhD principal investigator
Gent University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salt; Deficit (or Low) and Cystic Fibrosis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fractional sodium excretion (percent) (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.