Kidney StonesNCT01420354
Can a Spot Urine Replace or Improve 24 Hour Urine Collections in Kidney Stone Patients
An observational study of Kidney Stones, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will sought to determine if limited urine collections can provide similar or more informative data than standard 24-hour urine collections used to evaluate kidney stone formers. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Stones
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Dec 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving care at Vancouver General Hospital for their kidney stone disease.
Who may be able to join
- Patients who have been diagnosed as having calcium based urinary stones
- at least 19 years of age
- do not have any additional serious disease
Who cannot join
- Patients who do not have calcium based urinary stones (such as: uric acid, cystine, struvite)
- less than 19 years of age
- have a serious alternate disease
- Pregnancy
- Positive Urine Culture
- Active cancer
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- Recurrent urinary infections
- Gross hematuria
- Receiving treatment with thiazides (or alternatively can be enrolled if the patient is willing to stop treatment for 2 weeks prior to study)
- Inability to provide informed consent
- Investigator's refusal to include
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital, DHCC, Level 6, 2775 Laurel Street
Vancouver, British Columbia, V5Z 1M9
About this study
This study will sought to determine if limited urine collections can provide similar or more informative data than standard 24-hour urine collections used to evaluate kidney stone formers.
Read the detailed description
BACKGROUND Urinary stone disease is a common problem, causing significant morbidity and sometimes mortality. Stone disease affects 5-10% of the population during their lifetime and of these patients between 30-50% will have at least one recurrent episode.
Urinary stones arise due to crystallization and aggregation of supersaturated ion complexes in the urine. Depending on the concentration of various urinary constituents and the physicochemical characteristics of a given individual's urine (such as pH, volume, calcium citrate concentration etc.), different crystals may precipitate. Therefore therapy is tailored to the individual, based on stone composition and the results of the 24-hour urine collection. The majority of the stones are calcium based (calcium oxalate, calcium phosphate) while the remaining are comprised of uric acid, struvite, cystine or other substances.
While some stones can pass spontaneously, the majority will require some form of treatment, and more than 50% will require surgical intervention. Until the 1980s, treatment of upper urinary tract stones often involved extensive open surgical procedures5. With the introduction of extracorporeal shock-wave lithotripsy (ESWL) and refinements in endourological procedures like percutaneous nephrolithotomy (PCNL), ureteroscopy (URS) techniques, it has now become possible to treat stones in almost all cases without open surgery. Stone management can be divided into three treatment phases. The first phase involves treatment of acute pain and the drainage of an obstructed and possibly infected kidney. The second phase aims to either remove or disintegrate the stone. The third phase is directed towards the prophylaxis of stone recurrence .
The third phase involves the metabolic evaluation of the patient to identify possible risk factors for forming recurrent stones, which consists of a 24 hour urine analysis to determine the content of urinary components such as calcium or oxalate that play a major role in stone disease. High levels of oxalate and calcium contribute to kidney stones recurrences and therapy to reduce these two substances in the urine can reduce recurrence rates. Low levels of citrate also increase the risk for forming stones, and can be treated with alkali such as potassium citrate.
Collecting 24-hour urines for evaluation and therapy can be cumbersome for patients and often leads to incorrect collection, which may be detectable by measuring the amount of creatinine in each sample. Previous attempts to evaluate spot versus 24-hour urines have been made, but more studies are necessary to determine how they compare to the conventional 24-hour collection. A more convenient method for collecting urine samples will facilitate the treatment and future prevention of recurrent kidney stone disease.
The aim of this project is to determine whether spot urines collected separately at key times throughout the day are comparable to the conventional pooled 24-hour urine collection, and whether the former yield more accurate information in terms of the levels of urinary components. Perhaps a patient with normal values for a pooled 24-hour collection may show spikes in certain variables throughout the day that would not be discovered in the 24-hour sample. Furthermore, reducing the collection to a single time point would improve patient compliance making it easier to do subsequent follow-up collections.
HYPOTHESIS AND OBJECTIVES We hypothesize that spot urines can provide equivalent information to that provided by a 24-hour urine test. An added benefit would be if spot urines provide more information for the identification of risk factors in patients who have normal 24-hour urine tests. A third possibility is that our hypothesis is incorrect and that a 24-hour urine sample will provide the most useful data in formulating a stone prevention therapy for our patients.
- Conditions
- Kidney Stones
- Keywords
- Metabolic stones, kidney stones, renal calculi, metabolic evaluation
- Medical subject headings
- Kidney Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium supersaturation and the risk of Calcium Oxalate crystallization will be compared between individual spot urines and conventional 24-hour urine sample
Measured: 24 hours divided into 4 time frames (spot urines)
Secondary outcomes (1)
Identified risk factors for kidney stone patients will be compared between individual spot urines and conventional 24-hour urine sample: volume, pH, Urinary calcium, magnesium, oxalate, citrate, creatinine
Measured: 24 hours divided in 4 time frames (spot urines)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: The study was combined with our Urine and Stool Study (NCT01637506).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Paterson, Study director, University of British ColumbiaRoger Sutton, Study director, University of British ColumbiaMorris Pudek, Study director, University of British ColumbiaDirk Lange, Study director, University of British ColumbiaMeredith Cushing, Study director, Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420354
- Sponsor's protocol ID
- H08-02934
- Status last verified
- Mar 2017
- First submitted
- 18 Oct 2010
- Last updated
- 3 Mar 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 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Spot Urine Replace or Improve 24 Hour Urine Collections in Kidney Stone Patients
- ClinicalTrials.gov ID
- NCT01420354
- Acronym / sponsor ID
- H08-02934
- Conditions
- Kidney Stones
- Keywords
- Metabolic stones, kidney stones, renal calculi, metabolic evaluation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was combined with our Urine and Stool Study (NCT01637506).
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Aug 2011 (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.
This study will sought to determine if limited urine collections can provide similar or more informative data than standard 24-hour urine collections used to evaluate kidney stone formers.
Detailed description
BACKGROUND Urinary stone disease is a common problem, causing significant morbidity and sometimes mortality. Stone disease affects 5-10% of the population during their lifetime and of these patients between 30-50% will have at least one recurrent episode.
Urinary stones arise due to crystallization and aggregation of supersaturated ion complexes in the urine. Depending on the concentration of various urinary constituents and the physicochemical characteristics of a given individual's urine (such as pH, volume, calcium citrate concentration etc.), different crystals may precipitate. Therefore therapy is tailored to the individual, based on stone composition and the results of the 24-hour urine collection. The majority of the stones are calcium based (calcium oxalate, calcium phosphate) while the remaining are comprised of uric acid, struvite, cystine or other substances.
While some stones can pass spontaneously, the majority will require some form of treatment, and more than 50% will require surgical intervention. Until the 1980s, treatment of upper urinary tract stones often involved extensive open surgical procedures5. With the introduction of extracorporeal shock-wave lithotripsy (ESWL) and refinements in endourological procedures like percutaneous nephrolithotomy (PCNL), ureteroscopy (URS) techniques, it has now become possible to treat stones in almost all cases without open surgery. Stone management can be divided into three treatment phases. The first phase involves treatment of acute pain and the drainage of an obstructed and possibly infected kidney. The second phase aims to either remove or disintegrate the stone. The third phase is directed towards the prophylaxis of stone recurrence .
The third phase involves the metabolic evaluation of the patient to identify possible risk factors for forming recurrent stones, which consists of a 24 hour urine analysis to determine the content of urinary components such as calcium or oxalate that play a major role in stone disease. High levels of oxalate and calcium contribute to kidney stones recurrences and therapy to reduce these two substances in the urine can reduce recurrence rates. Low levels of citrate also increase the risk for forming stones, and can be treated with alkali such as potassium citrate.
Collecting 24-hour urines for evaluation and therapy can be cumbersome for patients and often leads to incorrect collection, which may be detectable by measuring the amount of creatinine in each sample. Previous attempts to evaluate spot versus 24-hour urines have been made, but more studies are necessary to determine how they compare to the conventional 24-hour collection. A more convenient method for collecting urine samples will facilitate the treatment and future prevention of recurrent kidney stone disease.
The aim of this project is to determine whether spot urines collected separately at key times throughout the day are comparable to the conventional pooled 24-hour urine collection, and whether the former yield more accurate information in terms of the levels of urinary components. Perhaps a patient with normal values for a pooled 24-hour collection may show spikes in certain variables throughout the day that would not be discovered in the 24-hour sample. Furthermore, reducing the collection to a single time point would improve patient compliance making it easier to do subsequent follow-up collections.
HYPOTHESIS AND OBJECTIVES We hypothesize that spot urines can provide equivalent information to that provided by a 24-hour urine test. An added benefit would be if spot urines provide more information for the identification of risk factors in patients who have normal 24-hour urine tests. A third possibility is that our hypothesis is incorrect and that a 24-hour urine sample will provide the most useful data in formulating a stone prevention therapy for our patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving care at Vancouver General Hospital for their kidney stone disease.
Key inclusion criteria (3 listed)
- Patients who have been diagnosed as having calcium based urinary stones
- at least 19 years of age
- do not have any additional serious disease
Key exclusion criteria (11 listed)
- Patients who do not have calcium based urinary stones (such as: uric acid, cystine, struvite)
- less than 19 years of age
- have a serious alternate disease
- Pregnancy
- Positive Urine Culture
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
Calcium supersaturation and the risk of Calcium Oxalate crystallization will be compared between individual spot urines and conventional 24-hour urine sample
Time frame: 24 hours divided into 4 time frames (spot urines)
1 secondary outcome
Identified risk factors for kidney stone patients will be compared between individual spot urines and conventional 24-hour urine sample: volume, pH, Urinary calcium, magnesium, oxalate, citrate, creatinine
Time frame: 24 hours divided in 4 time frames (spot urines)
Results and safety
The study was stopped early (reason given: The study was combined with our Urine and Stool Study (NCT01637506).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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.
Ryan Paterson study director
University of British Columbia
Roger Sutton study director
University of British Columbia
Morris Pudek study director
University of British Columbia
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 Stones, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 11 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 3 Mar 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 Canada. 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: The study was combined with our Urine and Stool Study (NCT01637506).). 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?
Calcium supersaturation and the risk of Calcium Oxalate crystallization will be compared between individual spot urines and conventional 24-hour urine sample (time frame: 24 hours divided into 4 time frames (spot urines)). 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 3 Mar 2017.