Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Response to low dose tolvaptan
研究概览
简要总结
This is a retrospective cohort study to assess the safety and efficacy of low first dose of Tolvaptan and low or standard second dose of Tolvaptan in patients with moderate to severe hyponatraemia associated with SIADH not responding to conservative means of hyponatraemia management.
Patients are treated as part of standard clinical care. There is growing evidence that treating patients with SAIDH induced hyponatraemia using a low dose of Tolvaptan with 7.5mg (below licensed lowest 15mg daily dose). This is the largest study to date and seeks to validate the efficacy and safety or this lower than approved dose of Tolvaptan in patietns who only need a first dose but also in patients who need a second low or srandard dose of Tolvaptan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presenting to Accident & Emergency department or seen as inpatients with moderate to severe hyponatraemia (sNa: <125mmol) associated with SIADH and not responding to conservative measures of hyponatraemia management.
- •Patients of all genders aged 18-90 y.o
排除标准
- •Pregnant women and patients aged < 18y.o
- •Hyponatraemia not associated with SIADH
研究组 & 干预措施
First dose tolvapatan
干预措施: Tolvaptan (Drug)
Second dose tolvaptan
干预措施: Tolvaptan (Drug)
结局指标
主要结局
Response to low dose tolvaptan
时间窗: Within 30 hours from tolvaptan intake
Evaluate the efficacy of tolvaptan 7.5mg daily to improve sodium concentration during inpatient hyponatraemia
Safety of low dose tolvaptan
时间窗: Within 30 hours from tolvaptan intake
Evaluate the magnitude of sodium increase after an initial 7.5mg Tolvaptan dose
次要结局
未报告次要终点