Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia
Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health