External Validation of Clinical Prediction Tools for Estimating Salt and Potassium Intake in Nephrology Patients.

Chronic Kidney Diseases Clinical Trial

— UniverSel  

Official title:

Multicenter External Validation of Clinical Prediction Tools for Estimating Salt and Potassium . Study UniverSel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783960
• Other study ID #: 69HCL23_0239
• Status: Recruiting
• Start date: July 16, 2023
• Est. completion date: January 8, 2025

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: Jean Pierre Fauvel, MD
• Phone: 04.72.11.01.56
• Email: jean-pierre.fauvel[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is no validated self-questionnaire to assess salt and potassium intake in nephrology patients.

Using Bayesian models, researchers developed clinical prediction tools to estimate salt and potassium intake in nephrology patients. These prediction tools performed well, with an accuracy of 89% for salt and 74% for potassium, and have undergone internal validation.

Currently, the investigators wish to conduct an external validation study of these clinical prediction tools using data from patients followed at 3 nephrologic centers to generalize the performance results of the tools.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 8, 2025
• Est. primary completion date: January 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female 18 years of age or older

• Consultant or inpatient in the nephrology department

• Having performed a 24-hour urinary assessment as part of his usual management with analysis of natriuresis and/or kaliuresis.

Exclusion Criteria:

• Patient having lost salt by vomiting, diarrhea and intense sweating (sport) in the week preceding the 24-hour urine collection.

• Person protected by the french law

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• administration questionary
Questionnaire will be compared to 24h sodium and potassium urinary excretion (reference). A Bayesian network and a multiple regression will be used to validate the questionary

Locations

Country	Name	City	State
France	Service de néphrologie Hôpitaux Universitaires de Strasbourg	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External multicenter validation questionary	comparison of answers to the questionnaire about salt and potassium diet with natriuresis and kaliuresis urinary excretion during 24 hours administrated in 3 centres in nephrology in France	at inclusion