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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06367894
Other study ID # STONECARE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 12, 2023
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Brugmann University Hospital
Contact Sirika Chhem
Phone 024772641
Email Sirika.Chhem@ulb.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Nearly 10% of the Belgian population suffer from kidney stone disease. Recent reviews reported that kidney stones represent an underestimated risk factor for further kidney function deterioration. Preventive measures are recommended in lithiases patients to prevent the formation of new stones. The individual effects of different medicated prosthetic interventions have been documented in clinical trials. However, there is little data on the effectiveness of combining these different preventive measures in routine clinical practice (real-world context). Patients with kidney stone disease require a complete metabolic assessment. The three main factors contributing to the stone's formation are the patient's metabolism, diet and lifestyle. Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hyperuricuria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes at minimum the 24h urine test, a blood test and spot urine test. Dietary habits and lifestyle are assessed by means of a questionnaire. The CHU Brugmann Hospital has a specialized multidisciplinary clinic for renal lithiases and mineral metabolism. Preventive personalized and interdisciplinary care in CHU Brugmann consists of a full metabolic work-up allowing the identification of lithogenic risk factors by nephrologists, dietary assessment by specialized dieticians and specific treatment protocol associated with regular follow-up. The aim of this study is to evaluate, in the context of a retrospective single-center cohort study, the effect of preventive personalized and interdisciplinary care on the evolution of all urinary lithogenic risk factors and the recurrence of kidney stones (rate of renal colics, emergency room admissions, and urological interventions).


Recruitment information / eligibility

Status Recruiting
Enrollment 164
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients of the CHU Brugmann Hospital who fulfill the criteria of active or past history of kidney stone, from 01/01/2018 till 31/10/2023 - Minimum follow-up time of 2 months with biochemical and clinical results available Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium CHU Brugmann Brussels

Sponsors (1)

Lead Sponsor Collaborator
Agnieszka Pozdzik

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of acute renal colics Number of acute renal colics From first patient consultation till 31/10/2023
Primary Number of emergency admissions Number of emergency admissions From first patient consultation till 31/10/2023
Primary Number of surgeries Number of surgeries From first patient consultation till 31/10/2023
Primary Number of hospitalizations Number of hospitalizations From first patient consultation till 31/10/2023
Primary Identified genetics abnormalities List of identified genetics abnormalities From first patient consultation till 31/10/2023
Primary Wisconsin questionnaire Changes in the quality of life in the patients (evolution of the scoring of the Wisconsin questionnaire) From first patient consultation till 31/10/2023
Primary Kidney function outcome Kidney function outcome Status at 31/10/2023
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