Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia
- Conditions
- Liver CirrhosisHyponatremia
- Interventions
- Other: conventional thearpy
- Registration Number
- NCT01850940
- Lead Sponsor
- Beijing Friendship Hospital
- 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 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.
- 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 are currently unknown.The objective of this study is to evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia. The secondary objective is to evaluate the short- to intermediate-term safety of tolvaptan in cirrhotic patients.This will be a phase IV, open-label, prospective cohort study for 7 days. Although not mandatory, study subjects are encouraged to undergo follow-up assessments at 1 month.Subjects will be evaluated at designated time points after initiation of therapy. The primary efficacy endpoint is the proportion of subjects with normal serum sodium level (135-145 mmol/l) on day 7. The secondary efficacy endpoints are 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tolvaptan Group Tolvaptan Tolvaptan,qd, po Conventional therapy conventional thearpy control group:Conventional therapy without tolvaptan
- Primary Outcome Measures
Name Time Method the proportion of subjects with normal serum sodium level (135-145 mmol/l) day 7 evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia
- Secondary Outcome Measures
Name Time Method change in sodium level from baseline day 7 and day 30 evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia
renal function day 7 and day 30 evaluate the short- to intermediate-term safety of tolvaptan in cirrhotic patients
mortality and liver-related complications day 7 and day 30 evaluate the short- to intermediate-term safety of tolvaptan in cirrhotic patients
quality of life (EQ-5D-3L) day 7 and day 30 evaluate the efficacy of tolvaptan in cirrhotic patients
change in body weight day 7 and day 30 evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia
edema day 7 and day 30 evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia
Trial Locations
- Locations (19)
Guangdong General Hospital
🇨🇳Guangdong, Guangdong, China
Beijing Ditan Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
85 Militay Hospital
🇨🇳Shanghai, Shanghai, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Youan Hospital
🇨🇳Beijing, Beijing, China
Shanghai Renji Hospital
🇨🇳Beijing, Beijing, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangdong, Guangdong, China
Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangdong, Guangdong, China
302 Military Hospital Integrative Medicine
🇨🇳Beijing, Beijing, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Huashan Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Xinhua Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Putuo District Central Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, Shanghai, China
302 Military Hospital Liver Failure Center
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China