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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01329042
Other study ID # UU01/47
Secondary ID
Status Completed
Phase Phase 4
First received April 4, 2011
Last updated April 4, 2011
Start date May 2005
Est. completion date February 2008

Study information

Verified date April 2011
Source Ouiheng International Healthcare Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 2008
Est. primary completion date October 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Potassium-sodium citrate
The treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Ouiheng International Healthcare Co., Ltd ChaingMai University, Chulalongkorn University, Prince Songkla University, Siriraj Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
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