Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05783960
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2023-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
External Validation of Clinical Prediction Tools for Estimating Salt and Potassium Intake in Nephrology Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 629}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'External multicenter validation questionary', 'timeFrame': 'at inclusion', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['salt diet', 'potassium diet', 'prediction tools', 'Bayesian network', 'kidney disease', 'epidemiology'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'There is no validated self-questionnaire to assess salt and potassium intake in nephrology patients.\n\nUsing 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.\n\nCurrently, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 years of age or older\n* Consultant or inpatient in the nephrology department\n* Having performed a 24-hour urinary assessment as part of his usual management with analysis of natriuresis and/or kaliuresis.\n\nExclusion Criteria:\n\n* Patient having lost salt by vomiting, diarrhea and intense sweating (sport) in the week preceding the 24-hour urine collection.\n* Person protected by the french law'}, 'identificationModule': {'nctId': 'NCT05783960', 'acronym': 'UniverSel', 'briefTitle': 'External Validation of Clinical Prediction Tools for Estimating Salt and Potassium Intake in Nephrology Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Multicenter External Validation of Clinical Prediction Tools for Estimating Salt and Potassium . Study UniverSel', 'orgStudyIdInfo': {'id': '69HCL23_0239'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'External validation a questionnaire', 'description': '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', 'interventionNames': ['Other: administration questionary']}], 'interventions': [{'name': 'administration questionary', 'type': 'OTHER', 'otherNames': ['administration questionary 27 items to evaluate the salt and potassium intake'], 'description': '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', 'armGroupLabels': ['External validation a questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'state': 'Alsace', 'country': 'France', 'facility': 'Service de néphrologie Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'AURAL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69400', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Lyon SUD', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'HÖPITAL bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jean Pierre Fauvel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service Nephrologie, Hôpital Edouard Herriot'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}