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

This study has been completed.
Sponsor:
Collaborators:
ChaingMai University
Prince Songkla University
Chulalongkorn University
Siriraj Hospital, Mahidol University
Information provided by:
Ouiheng International Healthcare Co., Ltd
ClinicalTrials.gov Identifier:
NCT01329042
First received: April 4, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted

April 4, 2011
April 4, 2011
May 2005
October 2007   (final data collection date for primary outcome measure)
rate of stone recurrence or stone growth [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
Same as current
No Changes Posted
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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
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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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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Calculi
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2008
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01329042
UU01/47
No
Bannakij Lojanapiwat, Division of urology, Department of surgery, Chiangmai University, Thailand
Ouiheng International Healthcare Co., Ltd
  • ChaingMai University
  • Prince Songkla University
  • Chulalongkorn University
  • Siriraj Hospital, Mahidol University
Principal Investigator: Bannakij Lojanapiwat, MD Division of Urology, Department of Surgery, Chiangmai University, Thailand
Ouiheng International Healthcare Co., Ltd
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP