Trial | NCT01329042  Report issue

Title

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

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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.
Study Started
May 31
2005
Primary Completion
Oct 31
2007
Study Completion
Feb 29
2008
Last Update
Apr 05
2011
Estimate

Drug Potassium-sodium citrate

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

  • Other names: Uralyt-U

Criteria 

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
No Results Posted