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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329042
First Posted: April 5, 2011
Last Update Posted: October 12, 2017
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.
Collaborators:
ChaingMai University
Prince Songkla University
Chulalongkorn University
Siriraj Hospital
Information provided by:
Ouiheng International Healthcare Co., Ltd
  Purpose
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 Intervention Phase
Kidney Calculi Drug: Potassium-sodium citrate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ouiheng International Healthcare Co., Ltd:

Primary Outcome Measures:
  • 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.


Enrollment: 80
Study Start Date: May 2005
Study Completion Date: February 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01329042


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

Responsible Party: Bannakij Lojanapiwat, Division of urology, Department of surgery, Chiangmai University, Thailand
ClinicalTrials.gov Identifier: NCT01329042     History of Changes
Other Study ID Numbers: UU01/47
First Submitted: April 4, 2011
First Posted: April 5, 2011
Last Update Posted: October 12, 2017
Last Verified: April 2011

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

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