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

NCT01329042 | Completed Phase 4

• 1 other identifier: UU01/47
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Calculi

Keywords

Potassium sodium citrate; stone recurrence; ESWL; PCNL; Hypocitraturia; intervention

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Potassium-sodium citrate DRUG

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

Also known as: Uralyt-U

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ouiheng International Healthcare Co., Ltd: lead
• Chiang Mai University: collaborator
• Prince Songkla University: collaborator
• Chulalongkorn University: collaborator
• Siriraj Hospital: collaborator

MeSH Terms

Conditions

Kidney Calculi

Interventions

magnesium citrate, potassium citrate, pyridoxine HCl, sodium citrate drug combination; Citrates

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Bannakij Lojanapiwat, MD

  Division of Urology, Department of Surgery, Chiangmai University, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 5, 2011
• Study Start: May 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: February 1, 2008
• Last Updated: April 5, 2011

Record last verified: 2011-04