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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

Primary Purpose

Kidney Calculi

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Potassium-sodium citrate
Sponsored by
Ouiheng International Healthcare Co., Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi focused on measuring Potassium sodium citrate, stone recurrence, ESWL, PCNL, Hypocitraturia, intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    rate of stone recurrence or stone growth
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2011
    Last Updated
    April 4, 2011
    Sponsor
    Ouiheng International Healthcare Co., Ltd
    Collaborators
    ChaingMai University, Prince Songkla University, Chulalongkorn University, Siriraj Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01329042
    Brief Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ouiheng International Healthcare Co., Ltd
    Collaborators
    ChaingMai University, Prince Songkla University, Chulalongkorn University, Siriraj Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Calculi
    Keywords
    Potassium sodium citrate, stone recurrence, ESWL, PCNL, Hypocitraturia, intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Potassium-sodium citrate
    Other Intervention Name(s)
    Uralyt-U
    Intervention Description
    The treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment
    Primary Outcome Measure Information:
    Title
    rate of stone recurrence or stone growth
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bannakij Lojanapiwat, MD
    Organizational Affiliation
    Division of Urology, Department of Surgery, Chiangmai University, Thailand
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    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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