Efficacy of Low Dose Tolvaptan for Treatment of Profound Hyponatremia in Syndrome of Inappropriate Antidiuresis (SIAD): The EFFLUX-FLUID Trial

Division of Nephrology, Department of Internal Medicine, Thammasat University Hospital0 个研究点目标入组 78 人开始时间: 2021年6月28日最近更新: 2024年8月19日

适应症

试验速览

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•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

发起方

Division of Nephrology, Department of Internal Medicine, Thammasat University Hospital