Kidney StoneNCT06367894
Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care
An observational study of Kidney Stone, run by Agnieszka Pozdzik at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- How many people
- 164 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Dec 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Agnieszka POZDZIK, 024772641, Agnieszka.POZDZIK@chu-brugmann.be
Sirika Chhem
About this study
Official title: 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.
Read more
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).
- Conditions
- Kidney Stone
- Medical subject headings
- Kidney Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acute renal colics
Number of acute renal colics
Measured: From first patient consultation till 31/10/2023
Number of emergency admissions
Number of emergency admissions
Measured: From first patient consultation till 31/10/2023
Number of surgeries
Number of surgeries
Measured: From first patient consultation till 31/10/2023
Number of hospitalizations
Number of hospitalizations
Measured: From first patient consultation till 31/10/2023
Identified genetics abnormalities
List of identified genetics abnormalities
Measured: From first patient consultation till 31/10/2023
Wisconsin questionnaire
Changes in the quality of life in the patients (evolution of the scoring of the Wisconsin questionnaire)
Measured: From first patient consultation till 31/10/2023
Kidney function outcome
Kidney function outcome
Measured: Status at 31/10/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start12 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agnieszka Pozdzik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Agnieszka Pozdzik, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367894
- Sponsor's protocol ID
- STONECARE
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care
- ClinicalTrials.gov ID
- NCT06367894
- Acronym / sponsor ID
- STONECARE
- Conditions
- Kidney Stone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Agnieszka PozdzikUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of acute renal colics
Time frame: From first patient consultation till 31/10/2023
Number of acute renal colics
Number of emergency admissions
Time frame: From first patient consultation till 31/10/2023
Number of emergency admissions
Number of surgeries
Time frame: From first patient consultation till 31/10/2023
Number of surgeries
Number of hospitalizations
Time frame: From first patient consultation till 31/10/2023
Number of hospitalizations
Identified genetics abnormalities
Time frame: From first patient consultation till 31/10/2023
List of identified genetics abnormalities
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)
Kidney function outcome
Time frame: Status at 31/10/2023
Kidney function outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone, run by Agnieszka Pozdzik at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sirika Chhem (024772641, Sirika.Chhem@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acute renal colics (time frame: From first patient consultation till 31/10/2023). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.