Skip to content

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01329042
Enrollment
80
Registered
2011-04-05
Start date
2005-05-31
Completion date
2008-02-29
Last updated
2011-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Calculi

Keywords

Potassium sodium citrate, stone recurrence, ESWL, PCNL, Hypocitraturia, intervention

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.

Interventions

DRUGPotassium-sodium citrate

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

Sponsors

Chiang Mai University
CollaboratorOTHER
Prince Songkla University
CollaboratorUNKNOWN
Chulalongkorn University
CollaboratorOTHER
Siriraj Hospital
CollaboratorOTHER
Ouiheng International Healthcare Co., Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
rate of stone recurrence or stone growth12 monthsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026