Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia
Hyponatremia
About this trial
This is an interventional treatment trial for Hyponatremia focused on measuring Hyponatremia, Dilutional Hyponatremia, Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Fluid Restriction, Tolvaptan
Eligibility Criteria
Inclusion Criteria:
- Cirrhosis
- Screening within 24 hours of admission
- Na level less than 130mEq/L
- Presence of fluid overload with either history of ascites or edema
- Cr < 2.0mg/dl
- Planned length of stay after randomization of at least 24 hours
- Anticipated survival of at least 8 days
- Ability to provide informed consent
Exclusion Criteria:
- Hospitalization greater than 24 hours at screening
- Depletional hyponatremia
- Hyponatremia due to hyperglycemia
- Acute and transient hyponatremia associated with head trauma or post-operative states
- Hyponatremia due to primary polydipsia, adrenal insufficiency, or hypothyroidism
- Urgent need for treatment of hyponatremia with saline or hypertonic saline
- Treatment with demeclocycline, lithium chloride, and urea
- Cr greater than 2.0mg/dl
- Stage 3 or 4 hepatic encephalopathy
- Inability to provide informed consent
- Planned discharge within 24 hours
- Anticipated survival less than 8 days
- GI bleeding within one month of enrollment
Sites / Locations
- NYU Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Tolvaptan
Subjects will receive placebo once daily. They will undergo the following procedures in every visit: Vitals (blood pressure, heart rate, respiration, temperature, weight, height), Laboratory Tests (chemistry, hematology, liver function, urine electrolytes, renin, and copeptin), ascites assessment, evaluation for edema. Quality of life assessments (SF-36, and LDQOL 1.0) will be administered on Day 1, Discharge day, Weeks 1-4 post-discharge, and months 2-6 post-discharge. Hepatic encephalopathy assessment (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.
Subjects will receive Tolvaptan once daily. They will undergo the following procedures in every visit: Vitals (blood pressure, heart rate, respiration, temperature, weight, height), Laboratory Tests (chemistry, hematology, liver function, urine electrolytes, renin, and copeptin), ascites assessment, evaluation for edema. Quality of life assessments (SF-36, and LDQOL 1.0) will be administered on Day 1, Discharge day, Weeks 1-4 post-discharge, and months 2-6 post-discharge. Hepatic encephalopathy assessment (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.