NCT04556162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2021

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

August 19, 2020

Last Update Submit

November 30, 2022

Conditions

Salt; Deficit (or Low)Cystic Fibrosis

Outcome Measures

Primary Outcomes (5)

  • fractional sodium excretion (percent)

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

    1 year

  • Urinary sodium/urinary creatinin (mmol/mmol)

    calculated based on urinary results

    1 year

  • Fractional Chloride excretion (percent)

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

    1 year

  • Fractional Potassium excretion (%)

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

    1 year

  • ratio urinary sodium/urinary potassium

    = calculation of ration urinary sodium/potassium

    1 year

Secondary Outcomes (2)

  • Body mass index

    1 year

  • Forced expiratory volume in 1 second

    1 year

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Stephanie Van Biervliet, MD, PhD

    Gent University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2020

First Posted

September 21, 2020

Study Start

January 1, 2018

Primary Completion

November 21, 2021

Study Completion

November 21, 2021

Last Updated

December 1, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)