Status:
COMPLETED
Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia
Lead Sponsor:
Beijing Friendship Hospital
Collaborating Sponsors:
Chinese University of Hong Kong
Conditions:
Liver Cirrhosis
Hyponatremia
Eligibility:
All Genders
18-70 years
Brief 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 ...
Detailed Description
Tolvaptan is an effective treatment for hyponatremia. However, cirrhotic patients were underrepresented in previous studies. The pattern of use and efficacy of tolvaptan in real-life clinical practice...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age no less than 18 years;
- Confirmed cirrhosis by histology or radiological features of cirrhosis and clinical features of portal hypertension;
- Serum sodium level less than 135 mmol/L;
- Inpatients.
- Exclusion criteria:
- Clinical features of hypovolemia;
- Systolic blood pressure less than 90 mmHg;
- Life expectancy less than one month;
- History of variceal bleeding in the last six months;
- Hepatic encephalopathy or peritonitis in the last two weeks;
- Serum creatinine more than 3.5 mg/dl;
- Severe cardiopulmonary disease;
- Urinary tract obstruction.
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01850940
Start Date
January 1 2013
End Date
May 1 2015
Last Update
July 28 2015
Active Locations (19)
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1
Beijing Ditan Hospital
Beijing, Beijing Municipality, China, 100018
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
4
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050