Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites (ECF)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01552590
Verified January 2013 by Korea Otsuka Pharmaceutical Co., Ltd.. Recruitment status was: Recruiting
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
20 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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)
Subject who are anuric as no benefit is expected
Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subject who has fluid depletion
Female subjects who are pregnant or lactating
Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason