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

Sponsor

Ouiheng International Healthcare Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01329042

Collaborator

ChaingMai University (Other), Prince Songkla University (Other), Chulalongkorn University (Other), Siriraj Hospital (Other)

Enrollment

33.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Calculi	Drug: Potassium-sodium citrate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Feb 1, 2008

Outcome Measures

Primary Outcome Measures

rate of stone recurrence or stone growth [12 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.