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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329042
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : April 5, 2011
ChaingMai University
Prince Songkla University
Chulalongkorn University
Siriraj Hospital
Information provided by:
Ouiheng International Healthcare Co., Ltd

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Potassium-sodium citrate
    The treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment
    Other Name: Uralyt-U

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329042

Sponsors and Collaborators
Ouiheng International Healthcare Co., Ltd
ChaingMai University
Prince Songkla University
Chulalongkorn University
Siriraj Hospital
Principal Investigator: Bannakij Lojanapiwat, MD Division of Urology, Department of Surgery, Chiangmai University, Thailand

Responsible Party: Bannakij Lojanapiwat, Division of urology, Department of surgery, Chiangmai University, Thailand Identifier: NCT01329042     History of Changes
Other Study ID Numbers: UU01/47
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011

Keywords provided by Ouiheng International Healthcare Co., Ltd:
Potassium sodium citrate
stone recurrence

Additional relevant MeSH terms:
Kidney Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi
Citric Acid
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action