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临床试验/NCT01420354
NCT01420354终止不适用

Can a Spot Urine Replace or Improve 24 Hour Urine Collections in Kidney Stone Patients

University of British Columbia1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
1
主要终点
Calcium supersaturation and the risk of Calcium Oxalate crystallization will be compared between individual spot urines and conventional 24-hour urine sample

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have been diagnosed as having calcium based urinary stones
  • at least 19 years of age
  • do not have any additional serious disease

排除标准

  • 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
  • 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

结局指标

主要结局

Calcium supersaturation and the risk of Calcium Oxalate crystallization will be compared between individual spot urines and conventional 24-hour urine sample

时间窗: 24 hours divided into 4 time frames (spot urines)

次要结局

  • 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(24 hours divided in 4 time frames (spot urines))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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