Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia

Completed

• Conditions: Liver Cirrhosis; Hyponatremia
• Interventions: Drug: Tolvaptan; 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-10
• Primary Completion: 2014-09
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

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
edema	day 7 and day 30	evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia
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

Trial Locations

Locations (19)

Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Youan Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai Renji Hospital; 🇨🇳 Beijing, Beijing, China

302 Military Hospital Integrative Medicine; 🇨🇳 Beijing, Beijing, China

302 Military Hospital Liver Failure Center; 🇨🇳 Beijing, Beijing, China

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangdong, Guangdong, China

Guangdong General Hospital; 🇨🇳 Guangdong, Guangdong, China

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