Chronic Kidney DiseasesUniverSelNCT05783960
External Validation of Clinical Prediction Tools for Estimating Salt and Potassium Intake in Nephrology Patients.
An observational study of Chronic Kidney Diseases, run by Hospices Civils de Lyon at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- administration questionary
- How many people
- 629 participants
- Where
- 5 sitesFrance
- Study dates
- 16 Jul 2023to 10 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
AURAL
Lyon, 69003
Hopital Lyon SUD
Lyon, 69400
HÖPITAL bichat
Paris, 75018
Service de néphrologie Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, 67000
CHU Rangueil
Toulouse, 31000
About this study
Official title: 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- administration questionary
- Keywords
- salt diet, potassium diet, prediction tools, Bayesian network, kidney disease, epidemiology
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration questionaryOther
Also called administration questionary 27 items to evaluate the salt and potassium intake
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: administration questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start16 Jul 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Pierre Fauvel, Principal investigator, Service Nephrologie, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783960
- Sponsor's protocol ID
- 69HCL23_0239
- Acronym
- UniverSel
- Status last verified
- Nov 2024
- First submitted
- 13 Mar 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter External Validation of Clinical Prediction Tools for Estimating Salt and Potassium . Study UniverSel
- ClinicalTrials.gov ID
- NCT05783960
- Acronym / sponsor ID
- UniverSel / 69HCL23_0239
- Conditions
- Chronic Kidney Diseases
- Keywords
- salt diet, potassium diet, prediction tools, Bayesian network, kidney disease, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Jul 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| External validation a questionnaire | – | Other: administration questionaryQuestionnaire 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administration questionaryAlso: administration questionary 27 items to evaluate the salt and potassium intakeQuestionnaire 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 | External validation a questionnaire |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Pierre Fauvel principal investigator
Service Nephrologie, Hôpital Edouard Herriot
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Hospices Civils de Lyon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External multicenter validation questionary (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.