- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06367894
Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care
Study on Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care
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).
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sirika Chhem
- Phone Number: 024772641
- Email: Sirika.Chhem@ulb.be
Study Contact Backup
- Name: Agnieszka POZDZIK
- Phone Number: 024752639
- Email: Agnieszka.POZDZIK@chu-brugmann.be
Study Locations
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Brussels, Belgium, 1020
- Recruiting
- CHU Brugmann
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Contact:
- Agnieszka POZDZIK
- Phone Number: 024772641
- Email: Agnieszka.POZDZIK@chu-brugmann.be
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Principal Investigator:
- Sirika Chhem
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of acute renal colics
Time Frame: From first patient consultation till 31/10/2023
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Number of acute renal colics
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From first patient consultation till 31/10/2023
|
Number of emergency admissions
Time Frame: From first patient consultation till 31/10/2023
|
Number of emergency admissions
|
From first patient consultation till 31/10/2023
|
Number of surgeries
Time Frame: From first patient consultation till 31/10/2023
|
Number of surgeries
|
From first patient consultation till 31/10/2023
|
Number of hospitalizations
Time Frame: From first patient consultation till 31/10/2023
|
Number of hospitalizations
|
From first patient consultation till 31/10/2023
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Identified genetics abnormalities
Time Frame: From first patient consultation till 31/10/2023
|
List of identified genetics abnormalities
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From first patient consultation till 31/10/2023
|
Wisconsin questionnaire
Time Frame: From first patient consultation till 31/10/2023
|
Changes in the quality of life in the patients (evolution of the scoring of the Wisconsin questionnaire)
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From first patient consultation till 31/10/2023
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Kidney function outcome
Time Frame: Status at 31/10/2023
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Kidney function outcome
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Status at 31/10/2023
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Pathological Conditions, Anatomical
- Urolithiasis
- Urinary Calculi
- Calculi
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Recurrence
- Kidney Calculi
- Nephrolithiasis
Other Study ID Numbers
- STONECARE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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