Kidney CalculiNCT02837393
Understanding the Urine Electrolyte Profile of the Individual Renal Unit
An observational study of Kidney Calculi and Nephrolithiasis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators objective is to determine if urinary electrolyte abnormalities exist in only one or both kidneys in participants with and without a history of kidney stones. To meet this objective, the investigators are going to take urine samples from each kidney at the time of kidney stone surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi, Nephrolithiasis, Urolithiasis
- What is being tested?
- Ureteral catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 1 Apr 2017
- 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: The study will be a prospective cohort study conducted within the Department of Urology at Johns Hopkins Hospital and Bayview Medical Center. The study population will be comprised of a convenience sample of participants 18 years of age or older who will be undergoing upper urinary tract surgery as part of routine clinical care for a diagnosis of nephrolithiasis, hematuria, ureteral stricture, ureteropelvic junction obstruction, hydronephrosis, or intra-operative identification of the ureters.
Who may be able to join
- Age ≥18 years of age
- Planed upper urinary tract surgery for a diagnosis of nephrolithiasis, hematuria, ureteral stricture, ureteropelvic junction obstruction, hydronephrosis, or intra-operative identification of the ureters.
Who cannot join
- History of an anatomic abnormality of the urinary tract.
- History of a solitary kidney.
- Untreated or a history of lower or upper urinary tract urothelial malignancy.
- Active urinary tract infection.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators objective is to determine if urinary electrolyte abnormalities exist in only one or both kidneys in participants with and without a history of kidney stones. To meet this objective, the investigators are going to take urine samples from each kidney at the time of kidney stone surgery. The samples will then be analyzed for absolute and relative differences in the concentrations of urine electrolytes, such as calcium.
Read the detailed description
Nephrolithiasis is common within the general population. Although the majority of patients with a symptomatic stone event will not require surgical intervention, the rate of recurrence is high. Therefore, reducing this rate of recurrence is important.
Traditionally, this has been achieved with a combination of serum and urine metabolic evaluation followed by targeted medication and dietary interventions. Specifically, it is recommended that a single 24-hour urine collection for analysis of urine electrolytes be performed. A 24-hour urine collection is bladder urine, which is pooled urine from both kidneys. The urine is then analyzed for the relative and absolute concentrations of electrolytes and small molecules known to be associated with stone formation. These include creatinine, calcium, citrate, oxalate, potassium, magnesium, phosphate, uric acid, and urate.
When an abnormality is detected on a 24-hour urine collection the assumption is that this is due to a global metabolic defect present in both kidneys. However, this may not be the case. It is possible there could be a relative imbalance with both kidneys having a defect, but to different degrees (or different defects in one or multiple electrolytes). It is also possible that one kidney has a dominant defect, but the contralateral kidney is normal, and therefore the 24-hour urine collection would only represent the dominant kidney with the defect. Finally, it is possible that the converse is true. One kidney has no defect, but the contralateral kidney has a minor defect. In this example, the 24-hour urine collection would appear normal as the dominant normal kidney masks the minor defect. This concept of differential kidney electrolyte handling was previously described in children. Therefore, understanding individual kidney metabolic profiles is important.
The purpose of the investigators' study will be to (1) characterize the urine electrolyte profile of each individual renal unit; (2) identify participants who have differences between their renal unit urine electrolyte profiles, and their renal units and bladder urine electrolyte profiles; and (3) correlate differences in renal unit urine electrolyte profiles with clinical manifestations of kidney stones, such as stone formation or growth. By characterizing individual renal unit urine electrolyte profiles, the investigators' may be able to isolate a phenotype of stone formers who would not otherwise be identified with traditional 24-hour urine collection. The investigators' can then target this phenotype in future investigations with dietary and medication interventions to hopefully prevent future stone events.
- Conditions
- Kidney Calculi, Nephrolithiasis, Urolithiasis
- Being tested
- Ureteral catheterization
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral catheterizationProcedure or surgery
During ureteral catheterization, urine samples will be obtain from each kidney
| Study group | Role | What they receive |
|---|---|---|
| History of Kidney Stones | Participants with a history of kidney stones who will be undergoing kidney surgery. Receives: Procedure: Ureteral catheterization | |
| No History of Kidney Stones | Participants without a history of kidney stones who will be undergoing kidney surgery. Receives: Procedure: Ureteral catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of urine electrolytes
The investigators' will determine if there is a difference in urine electrolyte concentrations within individuals between the two kidneys, and across individuals in those with and without a history of kidney stones.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Why it stopped: Low Recruitment and Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin B Ziemba, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837393
- Sponsor's protocol ID
- IRB00099408
- Status last verified
- Aug 2017
- First submitted
- 15 Jul 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Urine Electrolyte Profile of the Individual Renal Unit
- ClinicalTrials.gov ID
- NCT02837393
- Acronym / sponsor ID
- IRB00099408
- Conditions
- Kidney Calculi, Nephrolithiasis, Urolithiasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low Recruitment and Enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
The investigators objective is to determine if urinary electrolyte abnormalities exist in only one or both kidneys in participants with and without a history of kidney stones. To meet this objective, the investigators are going to take urine samples from each kidney at the time of kidney stone surgery. The samples will then be analyzed for absolute and relative differences in the concentrations of urine electrolytes, such as calcium.
Detailed description
Nephrolithiasis is common within the general population. Although the majority of patients with a symptomatic stone event will not require surgical intervention, the rate of recurrence is high. Therefore, reducing this rate of recurrence is important.
Traditionally, this has been achieved with a combination of serum and urine metabolic evaluation followed by targeted medication and dietary interventions. Specifically, it is recommended that a single 24-hour urine collection for analysis of urine electrolytes be performed. A 24-hour urine collection is bladder urine, which is pooled urine from both kidneys. The urine is then analyzed for the relative and absolute concentrations of electrolytes and small molecules known to be associated with stone formation. These include creatinine, calcium, citrate, oxalate, potassium, magnesium, phosphate, uric acid, and urate.
When an abnormality is detected on a 24-hour urine collection the assumption is that this is due to a global metabolic defect present in both kidneys. However, this may not be the case. It is possible there could be a relative imbalance with both kidneys having a defect, but to different degrees (or different defects in one or multiple electrolytes). It is also possible that one kidney has a dominant defect, but the contralateral kidney is normal, and therefore the 24-hour urine collection would only represent the dominant kidney with the defect. Finally, it is possible that the converse is true. One kidney has no defect, but the contralateral kidney has a minor defect. In this example, the 24-hour urine collection would appear normal as the dominant normal kidney masks the minor defect. This concept of differential kidney electrolyte handling was previously described in children. Therefore, understanding individual kidney metabolic profiles is important.
The purpose of the investigators' study will be to (1) characterize the urine electrolyte profile of each individual renal unit; (2) identify participants who have differences between their renal unit urine electrolyte profiles, and their renal units and bladder urine electrolyte profiles; and (3) correlate differences in renal unit urine electrolyte profiles with clinical manifestations of kidney stones, such as stone formation or growth. By characterizing individual renal unit urine electrolyte profiles, the investigators' may be able to isolate a phenotype of stone formers who would not otherwise be identified with traditional 24-hour urine collection. The investigators' can then target this phenotype in future investigations with dietary and medication interventions to hopefully prevent future stone events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| History of Kidney Stones | – | Procedure: Ureteral catheterizationParticipants with a history of kidney stones who will be undergoing kidney surgery. |
| No History of Kidney Stones | – | Procedure: Ureteral catheterizationParticipants without a history of kidney stones who will be undergoing kidney surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be a prospective cohort study conducted within the Department of Urology at Johns Hopkins Hospital and Bayview Medical Center. The study population will be comprised of a convenience sample of participants 18 years of age or older who will be undergoing upper urinary tract surgery as part of routine clinical care for a diagnosis of nephrolithiasis, hematuria, ureteral stricture, ureteropelvic junction obstruction, hydronephrosis, or intra-operative identification of the ureters.
Key inclusion criteria (2 listed)
- Age ≥18 years of age
- Planed upper urinary tract surgery for a diagnosis of nephrolithiasis, hematuria, ureteral stricture, ureteropelvic junction obstruction, hydronephrosis, or intra-operative identification of the ureters.
Key exclusion criteria (5 listed)
- History of an anatomic abnormality of the urinary tract.
- History of a solitary kidney.
- Untreated or a history of lower or upper urinary tract urothelial malignancy.
- Active urinary tract infection.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteral catheterizationDuring ureteral catheterization, urine samples will be obtain from each kidney | Procedure or surgery | History of Kidney Stones, No History of Kidney Stones |
Primary outcome
Concentrations of urine electrolytes
Time frame: 1 year
The investigators' will determine if there is a difference in urine electrolyte concentrations within individuals between the two kidneys, and across individuals in those with and without a history of kidney stones.
Results and safety
The study was stopped early (reason given: Low Recruitment and Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- 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.
Justin B Ziemba, MD principal investigator
Johns Hopkins School of Medicine
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 Calculi and Nephrolithiasis, run by Johns Hopkins University at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 18 Aug 2017. 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 United States. 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?
The study was stopped early (reason given: Low Recruitment and Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of urine electrolytes (time frame: 1 year). 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 18 Aug 2017.