CaOx Stone Prevention
ConditionKidney Stones
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This single-center randomized controlled trial at Mount Sinai West will enroll 80 patients undergoing percutaneous nephrolithotomy for calcium oxalate stones. Participants will be randomized to receive either empiric therapy or selective therapy guided by 24-hour urine evaluation. The primary outcome is change in calcium oxalate supersaturation at 4 weeks, aiming to determine whether empiric therapy can provide outcomes comparable to selective therapy while simplifying access to prevention.
Eligibility criteria
Qualifiers
Adult age of 18 years
Diagnosed with kidney stones and scheduled for PCNL.
Calcium Oxalate Stone Former
Pre-operative CT-scan within 90 days of surgery and stone density with > 1000 Hounsfield units
Disqualifiers
Documented history of gastric or intestinal bypass, liver disease, history of gastrointestinal malabsorptive disease (Crohn's disease, ulcerative colitis, and short-gut syndrome)
Hyperparathyroidism -Renal tubular acidosis
Active kidney stone prevention treatment (use of thiazides, alkaline therapy, or low oxalate diet) at the time of surgery
History of hypokalemia or baseline hypotension
Trial design
Treatments tested in this trial
- Chlorthalidone
- Low oxalate diet
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov