Evaluation of Salt Status in Patients With Cystic Fibrosis

NCT ID: NCT04556162

Last Updated: 2022-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-11-21

Brief Summary

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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

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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

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Salt; Deficit (or Low) Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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fractional sodium excretion

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

Intervention Type DIAGNOSTIC_TEST

risk subgroups

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Van Biervliet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gent University hospital

Locations

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Gent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BC-05673

Identifier Type: -

Identifier Source: org_study_id

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