Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia - A Multi-center Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 19
- 主要终点
- the proportion of subjects with normal serum sodium level (135-145 mmol/l)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tolvaptan Group
Tolvaptan,qd, po
干预措施: Tolvaptan (Drug)
Conventional therapy
control group:Conventional therapy without tolvaptan
干预措施: conventional thearpy (Other)
结局指标
主要结局
the proportion of subjects with normal serum sodium level (135-145 mmol/l)
时间窗: day 7
evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia
次要结局
- change in sodium level from baseline(day 7 and day 30)
- renal function(day 7 and day 30)
- mortality and liver-related complications(day 7 and day 30)
- quality of life (EQ-5D-3L)(day 7 and day 30)
- change in body weight(day 7 and day 30)
- edema(day 7 and day 30)
研究者
Jia Ji-Dong
Direcror of the Liver Research Center
Beijing Friendship Hospital