Is There a Role for Thyroid Hormones Treatment in the Set-up of Acute Moderate to Severe Asthma Exacerbation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- time to normalization of PEF (peak expiratory flow)
研究概览
简要总结
This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes.
The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation.
The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.
详细描述
Study population: The study will include adults admitted to Internal Medicine B (IMB) department, Internal Medicine H (IMH) department or medical intensive care unit (MICU) in Rambam-Health Care Campus for moderate to severe Asthma exacerbation. The severity of the exacerbation will be based on several acceptable clinical and laboratory criteria, including breathless, alertness, pulse rate, respiratory rate, partial pressure of oxygen in arterial blood (PaO2), partial pressure of carbon dioxide in arterial blood (PaCO2), oxygen saturation, peak expiratory flow (PEF). Study protocol: The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the PEF rate to normal values or personal base line. PEF rates will be examined first after initial bronchodilator therapy and then, every 8 hours.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Known Asthma
- •The exacerbation is defined as moderate or severe.
- •Not currently enrolled as an active participant in another clinical trial of a medical therapy or device.
- •The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy
排除标准
- •60 years of age or older
- •Known thyroid disorders
- •Subject where thyrotoxicosis is suspected
- •Known heart disease
- •Heart rate > 140
研究组 & 干预措施
IV thyroxin
IV thyroxin
干预措施: IV thyroxin (Drug)
control IV saline
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
time to normalization of PEF (peak expiratory flow)
时间窗: one week
The primary endpoint is the time to return of the PEF rate to normal values or personal base line.
次要结局
- heart rate(one week)
- Time to oxygenation(one week)
- Length of stay(one week)
- respiratory rate(one week)