Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy

Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy

Sponsors

Lead sponsor: University of British Columbia

Source University of British Columbia
Brief Summary

The aim of this research is to use a controlled laboratory setting to determine whether bacteria isolated from kidney stones of patients play a role in the formation of non-infectious kidney stones. It is well known that struvite stones are associated with active bacterial infection, however the role of bacteria in the formation of non-infection stones (like calcium oxalate) is not well characterized and there are theories that bacteria are involved in the making of these stones.

Detailed Description

Kidney stone disease is common, affecting nearly 10% of the population with increasing prevalence and increasing cost associated to treat this disease. While struvite stones (composed of magnesium, ammonium and phosphate crystals) have been associated with the presence of infection, the association between bacteria and non-infection stones is not well characterized. Previous studies have found bacteria present in stones of patients without active infection and with negative pre-operative urine tests.

There are various compositions of kidney stones, including calcium oxalate, calcium phosphate, struvite and uric acid, with calcium oxalate being the most common. It is well known that struvite stones are associated with active infection, however the role of bacteria in the formation of other types of kidney stones, including calcium oxalate, is not well understood. The investigators hypothesize that bacteria present in the urinary tract of patients without active infection have the ability to facilitate calcium oxalate crystal formation by providing a surface for stones to grow. An understanding of the role of bacteria in the formation of non-infection stones could help prevent stone formation by altering the bacteria present within patients to decrease or eliminate their risk of kidney stone disease.

Overall Status Completed
Start Date June 2016
Completion Date February 24, 2017
Primary Completion Date February 23, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Amount of stone formation in artificial urine with isolated bacteria from non-infection kidney stones compared to control measured using FTIR-Microscopy and SEM (concentration measured in mg/mL). Through study completion, approximately 2 years
Bacteria isolated from non-infection kidney stone compared to those identified on pre-operative urine test quantified by simple serial dilution and CFU counting (measured in CFU/mL) and identified using DNA sequencing. Through study completion, approximately 2 years
Enrollment 6
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Over the age of 18

- Diagnosed with or have a high index of suspicion of having a kidney stone and scheduled to undergo percutaneous nephrolithotomy.

- Medically fit for definitive surgical management of stone

Exclusion Criteria:

- Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.

- Patients who are unable to provide informed consent.

- 18 years old or younger

- Diagnosed with an infection stone

- Urinary tract infection within 3 months before date of operation

- Antibiotic use within 3 month before date of operation

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
The Stone Centre, VGH/UBC
Location Countries

Canada

Verification Date

November 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of British Columbia

Investigator full name: Dirk Lange

Investigator title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov