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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
Show all 11Show fewer
  • 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

Other trials in Canada

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.

  1. 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)
  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.

  1. First posted19 Aug 2011 (estimated)
  2. Study startAug 2009
  3. Primary completionDec 2016
  4. Study completionDec 2016

Why it stopped: The study was combined with our Urine and Stool Study (NCT01637506).

Resources

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)
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

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; AzTrials last refreshed its copy on 6 Nov 2026.

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