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

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.

Conditions

• Hyponatremia

Interventions

DRUG

Tolvaptan

15 mg once daily

DRUG

Placebo

15 mg once daily

BEHAVIORAL

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.

BEHAVIORAL

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

BIOLOGICAL

Vital signs

Vital signs (blood pressure, heart rate, respiration, temperature, weight, height) will be recorded at every visit.

BIOLOGICAL

Blood laboratory tests

Blood laboratory tests (chemistry, hematology, liver function, urine electrolytes, renin, and copeptin) will be recorded at every visit.

PROCEDURE

Ascites Evaluation

Ascites will be assessed at every visit.

PROCEDURE

Edema

Edema will be assessed at every visit.

Sponsors & Collaborators

• Otsuka America Pharmaceutical

  collaborator INDUSTRY

• NYU Langone Health

  lead OTHER

Principal Investigators

• Samuel Sigal, MD · NYU School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• United States

Study Locations