Efficacy of Potassium Sodium Hydrogen Citrate Therapy on Renal Stone Recurrence and/or Residual Fragments After Shockwave Lithotripsy and Percutaneous Nephrolithotomy in Calcium Oxalate Urolithiasis

Kidney Calculi Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329042
• Other study ID #: UU01/47
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2011
• Last updated: April 4, 2011
• Start date: May 2005
• Est. completion date: February 2008

Study information

• Verified date: April 2011
• Source: Ouiheng International Healthcare Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Extracorporeal shock wave lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL) become the therapy of choice for renal stone. Although providing good results, stone recurrence is usually found as the therapies do not change the underlying metabolic abnormality. Among the metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis. This study evaluate the preventive effects of potassium sodium citrate on stone recurrence as well as stone growth post ESWL or PCNL, in patients with calcium-containing stones.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• stone free or had residual calcium oxalate stone fragments with a less than 4 mm. diameter at eight weeks after ESWL or PCNL

Exclusion Criteria:

• renal tubular obstruction

• serum creatinine > 2 mg/dl

• urinary tract infection (bacteria > 100,000 in urine culture)

• hypersensitive or contraindication to Potassium sodium hydrogen citrate

• insertion Double-J Stent

• history of arrhythmia, myocardial infarction or digitalis administration

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

Intervention

Drug:
• Potassium-sodium citrate
The treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Ouiheng International Healthcare Co., Ltd	ChaingMai University, Chulalongkorn University, Prince Songkla University, Siriraj Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of stone recurrence or stone growth	The patients were evaluated at 6 months after the initial treatment for serum chemistry and urinalysis. After 12 months, all patients were evaluated for serum chemistry, urinalysis, 24-hour urine study and plain KUB.	12 months