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

NCT05783960 | Completed

• 1 other identifier: 69HCL23_0239
• Study Type: observational
• Target: 629
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Kidney Diseases

Keywords

salt diet; potassium diet; prediction tools; Bayesian network; kidney disease; epidemiology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

External validation a questionnaire

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

Other: administration questionary

Interventions

administration questionary OTHER

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

Also known as: administration questionary 27 items to evaluate the salt and potassium intake

External validation a questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of patients consulting or hospitalized in day hospital in the nephrology department of one of the three centers participating in the study: Hôpital Lyon Sud (Hospices Civils Lyon), AURAL (Association pour l'Utilisation du Rein Artificiel dans la région Lyonnaise) Lyon and Hôpitaux Universitaires de Bordeaux. It is therefore composed of patients suffering from different types of nephropathy (lithiasis, diabetes, hypertension, tubulo interstitial, glomerular, autosomal dominant polycystic or other) whatever the stage of their disease and of healthy volunteers (living donors).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

Service de néphrologie Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, 67000, France

Location

AURAL

Lyon, 69003, France

Location

Hopital Lyon SUD

Lyon, 69400, France

Location

HÖPITAL bichat

Paris, 75018, France

Location

CHU Rangueil

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Pierre Fauvel

  Service Nephrologie, Hôpital Edouard Herriot

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: July 16, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

FR (5)