Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia

Launched by NYU LANGONE HEALTH · Jun 27, 2013

Keywords

ClinConnect Summary

As per hyponatremia standard treatment of care, all patients considered for the study will have had diuretic therapy discontinued for at least 1 day prior to the screening visit and received volume expansion with 25% salt poor albumin, if clinically indicated to ensure adequate intravascular volume expansion as standard of care for a patient hospitalized for complications of cirrhosis.

Patients will be approached and presented with a written consent form during the first 24 hours of their admission to NYUMC (Tisch Hospital). They will be verbally informed about the purpose and procedures o...

Gender

ALL

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