Renal urolithiasis
Conditions
Interventions
Potassium Citrate group (experimental): Three tablets daily (30 mEq) orally, which must be swallowed whole, with plenty of fluids and divided into 3 frequencies (30 minutes after breakfast, lunch and
Tablets
Administration, Oral
Acalka
Sponsors
Oriente Pharmaceutical Laboratory Company
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1- Adults (19-75 years, both inclusive). 2- Patients who have given their informed consent to participate in the study. 3- Patients who present in the urine metabolic study any of the metabolic alterations of hypercalciuria, hyperuricosuria, hyperoxaluria, hypocitraturia or cystinuria. 4- Patients who comply with the washout period (do not take any urinary alkalinizing medication) of 10 days or more, before recruitment.
Exclusion criteria
Exclusion criteria: 1- Patients with struvite stones. 2- Patients with urinary infection. 3- Patients with a history of hyperkalemia or at risk of it (glomerular filtration rate less than 25 ml / min x 1.73 m2SC). 4- Patients with metabolic alkalosis (HCO3- in plasma greater than 33mEq / l). 5- Patients with a history of gastritis or active peptic ulcer, with delayed gastric emptying, with esophageal compression, obstruction or intestinal stricture. 6- Patients who are taking anticholinergic medications. 7- Patients who present any mental or physical condition that prevents them from collecting 24-hour urine. 8- Pregnant and postpartum patients who are breastfeeding. 9- Diabetic patients decompensated from the disease. 10- Patients who are taking potassium-sparing diuretics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Excretion of citrate in the urine (citraturia). Measurement time: At baseline, 15 days, and 3 months. 2. Variation in urinary pH. Measurement time: At baseline, 15 days, and 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events-AE (Occurrence of any AE (Yes or No), Description of AE (Name of the AE, according to the clinical manifestation that occurs), Severity of the adverse event (Serious / non-Serious), AE intensity (Mild, Moderate, Severe), Duration of the AE (Start and End dates of the adverse event), Causal relationship (Very probable / certain, probable, possible, unlikely, unrelated, not evaluable / not classifiable), Attitude towards treatment (No changes, temporary or definitive interruption of the treatment under study), AE result (Recovered, improved, persists, sequelae, death due to AE, or unknown), Lot (Lot code of the drug causing the AE)). Measurement time: 3 months. | — |
Countries
Cuba
Contacts
Public ContactPedro Guerra Chaviano
National Coordinating Center for Clinical Trials (CENCEC)
Outcome results
None listed