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

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Other: administration questionary

• Registration Number: NCT05783960
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Study Start: 2023-07-16
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
External validation a questionnaire	administration questionary	Questionnaire will be administrated to patient with chronic kidney diseases ti evaluated the consumption of salt and potassium intake. A Bayesian network and a multiple regression will be used to validated the questionary of 27 items

Primary Outcome Measures

Name	Time	Method
External multicenter validation questionary	at inclusion	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

Trial Locations

Locations (5)

AURAL; 🇫🇷 Lyon, France

Hopital Lyon SUD; 🇫🇷 Lyon, France

HÖPITAL bichat; 🇫🇷 Paris, France

CHU Rangueil; 🇫🇷 Toulouse, France

Service de néphrologie Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, Alsace, France