Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase IV, open-label, prospective cohort study for 7 days.The recommended starting dose of tolvaptan is 15 mg daily orally. The dose may be titrated on the next day at 15 mg intervals up to 60 mg daily according to the serum sodium level response.Serum sodium level, change in sodium level from baseline, quality of life (EQ-5D-3L), change in body weight, edema, renal function, mortality and liver-related complications on day 7 and day 30 to evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital
• Collaborator: Chinese University of Hong Kong
• Treatments: Tolvaptan

Criteria

Inclusion criteria:

1. Age no less than 18 years;

2. Confirmed cirrhosis by histology or radiological features of cirrhosis and clinical features of portal hypertension;

3. Serum sodium level less than 135 mmol/L;

4. Inpatients.

Exclusion criteria:

1. Clinical features of hypovolemia;

2. Systolic blood pressure less than 90 mmHg;

3. Life expectancy less than one month;

4. History of variceal bleeding in the last six months;

5. Hepatic encephalopathy or peritonitis in the last two weeks;

6. Serum creatinine more than 3.5 mg/dl;

7. Severe cardiopulmonary disease;

8. Urinary tract obstruction.