Brushite Kidney Stones: A Registry and Database of Clinical and Laboratory Findings

Nephrolithiasis Clinical Trial

Official title:

Brushite Stones: A Registry and Database of Clinical and Laboratory Findings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169663
• Other study ID #: 03-049
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: April 23, 2012
• Start date: July 2003
• Est. completion date: November 2010

Study information

• Verified date: April 2012
• Source: Indiana Kidney Stone Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Brushite kidney stones are a unique form of calcium phosphate stones that have a tendency to recur quickly if patients are not aggressively treated with stone prevention measures. Little research has been undertaken to better understand the clinical history and potential urinary abnormalities that may predispose one to these troublesome kidney stones.

Description:

Multiple treatment options are available for the treatment of kidney or ureteral calculi. Treatment options include shock wave lithotripsy (SWL; shock waves are transmitted through the body wall and focused onto the stone to break the stone into gravel), percutaneous nephrolithotomy (PNL; a small flank incision is made and a telescope inserted into the kidney to allow stone fragmentation and removal from the patient), and ureteroscopic lithotripsy (URS; a small telescope is inserted into the ureter or kidney and a laser is used to break up the stone into gravel).

Brushite is a unique form of calcium phosphate kidney stone that often has sub-optimal stone fragmentation with shock wave lithotripsy (Heimbach et al, 1999). Due to its SWL resistance, brushite patients often undergo more invasive treatments such as URS or PNL to achieve a stone free status. Brushite patients often have multiple stones and have a high likelihood of developing recurrences (new stone formation or regrowth of existing stone fragments), often within the first year after surgery. These patients may also have a history of anatomical abnormalities of the urinary tract or a history of prior renal or ureteral surgery (Klee et al, 1991).

A thorough review of the clinical, radiological and metabolic data of brushite patients has the potential to clarify a number of important points. Many patients with brushite stones often have a history of non-brushite stones (e.g. calcium oxalate) predating the development of brushite stones and historical review is needed to define the factors contributing to this shift in stone composition. In addition, it has been shown that CT attenuation values can be used to predict stone composition (Joseph et al, 2002). As a result, it is crucial to review the radiologic appearance of known brushite stones to identify specific radiographic characteristics and possibly allow a radiographic diagnosis of brushite to be established. Finally, very little information has been reported on the urinary abnormalities in brushite patients. By carefully examining 24 hour urine data in a large population of brushite patients, information may be identified that can be used to provide improved management of specific abnormalities to prevent stone recurrences.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients of Methodist Urology in Indianapolis, IN over the age of 18 with brushite stones.

Exclusion Criteria:

1. Patients unable to give informed consent

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Nephrolithiasis

Locations

Country	Name	City	State
United States	Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana Kidney Stone Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To review the clinical and laboratory findings in a population of brushite patients who have been treated at Methodist Urology, LLC		one year	No