Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With As… (NCT01552590) | Clinical Trial Compass
TerminatedPhase 4
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
South Korea74 participantsStarted 2012-04
Plain-language summary
This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and hyponatremia
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects aged ≥ 20 years
✓. Subjects who have been diagnosed with hyponatremia \[serum sodium \< 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction\]
✓. Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
✓. Subjects who have diagnosed with cirrhosis.
✓. Subject or their legally acceptable representatives are able to provide informed consent/assent.
Exclusion criteria
✕. Subject who has ascites by other causes (Tbc, CHF, malignancy, or renal disease) acute severe hyponatemia : Serum Na level \< 120 mmol/L and Doubt of symptom caused by hyponatremia and the case which should raise serum Na level urgently based on the investigator's judgment international normalized ratio (INR) \>3.0 serum sodium ≥135 mmol/L serum potassium \> 5.5 mmol/L Creatinine ≥ 2.0 mg/dL Hepatorenal syndrome defined as 'New International Ascites Club's diagnostic criteria' systolic arterial pressure of \< 80 mmHg recent myocardial infarction (\< 6 month) spontaneous bacterial peritonitis gastrointestinal bleed ( ≤7 days from randomization) ongoing hepatic encephalopathy of \> grade1 known hepatocellular carcinoma intractable ascites
✕. Subject who requiring urgent intervention to raise serum sodium acutely
✕. Subject who are unable to sense or to respond appropriately to thirst
✕. Subject with hypovolemic hyponatremia
✕. Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)