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

November 13, 2024 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

629

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • AURAL
      • Lyon, France, 69400
        • Hopital Lyon Sud
      • Paris, France, 75018
        • Hopital Bichat
      • Toulouse, France, 31000
        • CHU Rangueil
    • Alsace
      • Strasbourg, Alsace, France, 67000
        • Service de néphrologie Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Other Names:
  • administration questionary 27 items to evaluate the salt and potassium intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External multicenter validation questionary
Time Frame: 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
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean Pierre Fauvel, Service Nephrologie, Hôpital Edouard Herriot

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2023

Primary Completion (Actual)

July 10, 2024

Study Completion (Actual)

July 10, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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