Profound hyponatremic patients who are diagnosed with syndrome of inappropriate antidiuresis (SIAD). hyponatremia, syndrome of inappropriate antidiuresis, SIAD, tolvaptan, fluid restriction, furosemide, sodium chloride
Conditions
Interventions
Tolvaptan 7.5 mg/day for 28 days,Fluid restriction 800 ml/day + furosemide 20-40 mg/day + sodium chloride tablet 3 g/day for 28 days
Experimental Drug,Active Comparator Drug
Tolvaptan,Fluid restriction plus furosemide and sodium chloride
Sponsors
Division of Nephrology, Department of Internal Medicine, Thammasat University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum sodium day 4 after randomization mmol/L | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactPajaree Krisanapan
Thammasat University Hospital
Outcome results
None listed