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

Ouiheng International Healthcare

Status and phase: Completed; Phase 4

Conditions: Kidney Calculi

Treatments: Drug: Potassium-sodium citrate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01329042

UU01/47

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)