NCT00592566终止2 期
An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand.
Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (> 14 years) with suspected severe leptospirosis
- •patients who presented with acute fever (oral temperature more than 38.00 C for <15 days) in the absence of an obvious focus of infection
- •In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).
排除标准
- •pregnant or breastfeeding
- •those with history of bleeding disorder
- •those who had underlying diseases such as chronic liver disease, diabetes mellitus
- •those who received diuretic or glucocorticoid
研究组 & 干预措施
2
Experimental
Dexamethasone treatment
干预措施: Dexamethasone, desmopressin (Drug)
3
Experimental
Desmopressin treatment
干预措施: Dexamethasone, desmopressin (Drug)
结局指标
主要结局
Survival
时间窗: during in hospital admission
次要结局
- Days of mechanical ventilation(during hospital admission)
研究者
研究点 (1)
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