NCT01631305已完成4 期
Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.
Sinaloa Pediatric Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit.
详细描述
Children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit, will be randomised to receive either Levothyroxine or placebo, to determine if it diminishes mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children aged 1 month to 17 years.
- •Admitted to pediatric intensive care unit.
- •TSH and thyroid hormones below age specific levels.
排除标准
- •Known thyroid condition.
- •Brain death.
- •Gut conditions that contraindicate oral route.
- •Readmissions to intensive care unit.
研究组 & 干预措施
Control
Placebo Comparator
Calcium magnesia.
干预措施: Calcium magnesia (Other)
Levothyroxine
Experimental
3 mcg/kg/day
干预措施: Levothyroxine (Drug)
结局指标
主要结局
All cause mortality
时间窗: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
次要结局
- Use of vasopressors(participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- Length of time in intensive care(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Ventilation days(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Thyroid hormones levels(participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
研究者
Jesús Javier Martínez-García
Principal investigator
Sinaloa Pediatric Hospital
研究点 (1)
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