Efficacy of Low Dose Tolvaptan for Treatment of Profound Hyponatremia in Syndrome of Inappropriate Antidiuresis (SIAD)
- Conditions
- Profound hyponatremic patients who are diagnosed with syndrome of inappropriate antidiuresis (SIAD).hyponatremia, syndrome of inappropriate antidiuresis, SIAD, tolvaptan, fluid restriction, furosemide, sodium chloride
- Registration Number
- TCTR20210628004
- Lead Sponsor
- Division of Nephrology, Department of Internal Medicine, Thammasat University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 78
1. Age at least 18 years old, 2. Significant hyponatremia [Na+] equal or less than 125 mmol/L, 3. Chronic hyponatremia, 4. Diagnosis of SIAD which all following criteria must be met; effective serum osmolality less than 275 mOsm/kg, urine osmolality more than 100 mOsm/kg H2O, clinical euvolemia, urine [Na+] more than 30 mmol/L with normal dietary salt and water intake, 5. The patients have a likelihood of failure from fluid restriction alone at least one of the following criteria; high urine osmolality (higher than 500 mOsm/kg H2O), sum of the urine Na+ and K+ concentrations exceeds the serum Na+ concentrations, 24-hour urine volume less than 1500 mL/d.
1. Hypothyroidism (thyroid-stimulating hormone less than 10 mIU/mL) 2., Glucocorticoid deficiency (unstimulated or stimulated cortisol level equal or less than 10 ug/dL), 3. significant renal insufficiency (define as GFR less than 60 ml/min/1.73m2 or diagnosed as acute renal injury), 4. Clinical overt hypovolemia or hypervolemia, 5. Decompensated liver cirrhosis, symptomatic heart failure, and nephrotic syndrome, 6. Hemodynamic unstable, 7. Current using investigational agents (salt tablet or furosemide) and other diuretics, 8. Severe symptomatic hyponatremia at enrollment (defined as vomiting, cardiorespiratory distress, abnormal and deep somnolence, seizures, and coma, 9. Hyperglycemia enough to interfere with assessment of [Na+], defined as random plasma glucose more than 300 mg/dL at the time of diagnosis, 10. Concomitant use of strong CYP 3A inhibitors such as clarithromycin, ketoconazole, itraconazole, ritonavir, and indinavir, 11. Pregnant or breast feeding woman, 12. Receiving renal replacement therapy, 13. Post kidney transplant status, 14. Furosemide or tolvaptan allergy, 15. Contraindicated for eating or feeding via enteral route. 16. Life expectancy less than 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum sodium day 4 after randomization mmol/
- Secondary Outcome Measures
Name Time Method Change in serum sodium day 7, 14, and 28 after randomization mmol/L,Time to reach serum sodium at least 130 mmol/L 28 days day,Time to reach serum sodium at least 135 mmol/L 28 days day,Percentage of patients to reach serum sodium at least 130 mmol/L 28 days person,Percentage of patients to reach serum sodium at least 135 mmol/L 28 days person,Overly rapid sodium correction 28 days event