ACTRN12619001683123已完成3 期
Open-label randomised controlled trial of tolvaptan versus fluid restriction in acutely hospitalised patients with euvolaemic or hypervolaemic hyponatraemia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Acutely hospitalised patients with hypotonic hyponatraemia (serum sodium 115-130 mmol/L) at 0800 hours on day 1 of their hospital admission (day of presentation being day 0).
排除标准
- •Hypovolaemia
- •Acute polydipsia (urine specific gravity < 1.003)
- •Severe symptoms warranting hypertonic saline (vomiting, coma (GCS <8), deep somnolence (sedation score >1), seizure, respiratory arrest)
- •Thiazide or thiazide-like diuretic use within preceding 5 days
- •Risk factors for osmotic demyelination syndrome (malnutrition, alcohol abuse, Child-Pugh B or C cirrhosis, potassium < 3.5 mmol/L on day 1, increment in serum sodium from day 0 to day 1 of > 0.5mmol/L/h or > 10 mmol/L).
- •Systolic blood pressure <100mmHg
- •Glucocorticoid deficiency
- •Mineralocorticoid deficiency
- •Overt hypothyroidism
- •Chronic kidney disease stage 5
- •Inability to drink fluid unaided
- •Pregnancy or breastfeeding
- •Marked hyperglycaemia (Day 1 venous blood gas glucose > 20 mmol/L)
研究者
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