Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care

April 11, 2024 updated by: Agnieszka Pozdzik

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

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Number of acute renal colics
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
Identified genetics abnormalities
Time Frame: From first patient consultation till 31/10/2023
List of identified genetics abnormalities
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)
From first patient consultation till 31/10/2023
Kidney function outcome
Time Frame: Status at 31/10/2023
Kidney function outcome
Status at 31/10/2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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