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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

Phase 4
Completed
Conditions
Kidney Calculi
Registration Number
NCT01329042
Lead Sponsor
Ouiheng International Healthcare Co., Ltd
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
rate of stone recurrence or stone growth12 months

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.

Secondary Outcome Measures
NameTimeMethod
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