2
Participants
Start Date
March 31, 2012
Primary Completion Date
March 31, 2015
Study Completion Date
March 31, 2015
Tolvaptan
15 mg once daily
Placebo
15 mg once daily
Hepatic Encephalopathy Assessment
The Number connection test, Digit symbol test, Constructional apraxia, Inhibitory control test, Repeatable Battery for the Assessment of Neuropsychological Status will be administered on Days 1, 2, 4, 6, and 8; discharge day; Weeks 1-4 post-discharge; and Months 2-6 post-discharge.
Quality of Life Assessment
The SF-36 and Liver Disease Questionnaire will be administered on Day 1, Discharge day, Weeks 1-4 post-discharge, and months 2-6 post-discharge
Vital signs
Vital signs (blood pressure, heart rate, respiration, temperature, weight, height) will be recorded at every visit.
Blood laboratory tests
Blood laboratory tests (chemistry, hematology, liver function, urine electrolytes, renin, and copeptin) will be recorded at every visit.
Ascites Evaluation
Ascites will be assessed at every visit.
Edema
Edema will be assessed at every visit.
NYU Langone Medical Center, New York
Collaborators (1)
Otsuka America Pharmaceutical
INDUSTRY
NYU Langone Health
OTHER