Evaluation of Salt Status in Patients With Cystic Fibrosis

Sponsor

University Hospital, Ghent (Other)

Overall Status

Unknown status

CT.gov ID

NCT04556162

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Salt; Deficit (or Low) Cystic Fibrosis	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Jan 1, 2021

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gent University Hospital	Gent		Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Stephanie Van Biervliet, MD, PhD, Gent University hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT04556162

Other Study ID Numbers:

BC-05673

First Posted:

Sep 21, 2020

Last Update Posted:

Oct 5, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Oct 5, 2020