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

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Hyponatremia is a condition in which there is a low sodium level in the blood. Individuals with cirrhosis may develop low blood sodium as a complication of their liver disease. In these patients, the presence of low blood sodium may exacerbate other complications such as encephalopathy, resulting in confusion, drowsiness, or coma. It may also affect the ability of the body to fight infection. In certain cases, cirrhotic patients may be hospitalized for the treatment of their low blood sodium.

The drug tolvaptan is currently FDA approved for the treatment of hyponatremia in patients with cirrhosis. Although it has been shown to increase the sodium level, the clinical trials that led to its approval did not otherwise assess clinical benefit of the drug.

This study is designed to determine whether patients with cirrhosis derive a clinical benefit when they receive tolvaptan for the treatment of hyponatremia within 2 days of admission. Specifically, whether it is associated with shortened length of stay and improvement in other complications of cirrhosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: Otsuka America Pharmaceutical
• Treatments: Tolvaptan

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