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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:
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Calcium Potassium
U.S. FDA Resources

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 ] [ 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329042

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

No publications provided

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
Study First Received: April 4, 2011
Last Updated: April 4, 2011
Health Authority: Thailand: Ministry of Public Health

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

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
 Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013