Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care

Kidney Stone Clinical Trial

Official title:

Study on Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367894
• Other study ID #: STONECARE
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Recurrence

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