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

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.

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Key information

Conditions

Kidney Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Potassium-sodium citrate

Drug

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

Other names: Uralyt-U

Primary outcomes

rate of stone recurrence or stone growth

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ouiheng International Healthcare Co., Ltd

Industry

Collaborators

Chiang Mai University
Chulalongkorn University
Prince Songkla University
Siriraj Hospital

Registry information

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2008
First posted: Apr 5, 2011
Registry last updated: Apr 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed