Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy

NCT02739919 | Completed

• 1 other identifier: H16-00637
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Keywords

Kidney stones; Renal Calculi

Outcome Measures

Primary Outcomes (2)

• 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).

  Bacteria will be isolated from non-infection kidney stones allowed to form a biofilm. Next, the bacteria will be incubated in supersaturated artificial urine to precipitate stone formation in vitro and compared to control urine consisting of the same artificial urine without bacteria. Over time, crystallization in the biofilm will be measured using FTIR-Microscopy and SEM.

  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.

  Bacteria will be quantified using simple serial dilution and CFU counting and identified using DNA sequencing. Bacteria will then be correlated with the bacteria identified on pre-operative urine test.

  Through study completion, approximately 2 years

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Vancouver General Hospital that are diagnosed with a kidney stone and scheduled to undergo percutaneous nephrolithotomy.

You may qualify if:

• 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

You may not qualify if:

• Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
• Patients who are unable to provide informed consent.
• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

The Stone Centre, VGH/UBC

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

De-identified and study coded kidney stone and urine samples are collected, processed and analysed in the research laboratory.

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk Lange, MSc, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Ben H Chew, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 15, 2016
• Study Start: June 1, 2016
• Primary Completion: February 23, 2017
• Study Completion: February 24, 2017
• Last Updated: May 2, 2018

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)