Low Dose Euthyrox in Treatments of Paraquat Intoxication: a Randomized, Controlled, Multicenter Trial in China.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- Rate of death yearly
研究概览
简要总结
Paraquat is a common human toxicant and accounts for 20 deaths per million persons in the world. Paraquat usually cause multiple organ dysfunction syndrome, including liver, kidney, lung and heart dysfunction. Besides, pituitary insufficiency also occurs on those patients with paraquat poisoning, which leads to multiple endocrine gland dysfunction, involving adrenal gland, thyroid and sex gland.
As a result, the investigators decide to initiate the clinical trial to find whether thyroid replacement therapy can furtherly reduce the mortality, and improve patients long-term prognosis.
详细描述
Paraquat is a common human toxicant and accounts for 20 deaths per million persons in the world. Its accidental or deliberate ingestion is associated with a high mortality rate ranging from 40% to 70%. Paraquat usually cause multiple organ dysfunction syndrome, including liver, kidney, lung and heart dysfunction. Besides, pituitary insufficiency also occurs on those patients with paraquat poisoning, which leads to multiple endocrine gland dysfunction, involving adrenal gland, thyroid and sex gland. Nowadays, steroids, as a hormone replacement therapy, is one of most important drugs for paraquat poisoning, and it has decreased patients' mortality greatly since using it. However, the clinicians have not paid enough attention to thyroid replacement therapy, as thyroid dysfunction is also the key pathophysiological course when paraquat poisoning occurs.
As a result, the investigators decide to initiate the clinical trial to find whether thyroid replacement therapy can furtherly reduce the mortality, and improve patients long-term prognosis.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all the patients who are diagnosed by paraquat poisoning
排除标准
- •patients who can not cooperate with the trial; patients who would not like to join in the trial.
研究组 & 干预措施
Experimental therapy group
Besides Traditional therapy，patients in this group will also receive thyroid replacement therapy.
干预措施: Levothyroxine Sodium (Drug)
Experimental therapy group
Besides Traditional therapy，patients in this group will also receive thyroid replacement therapy.
干预措施: Traditional therapy (Drug)
Traditional therapy group
Patients in Standard therapy group will receive treatments according to guideline worldwide.
干预措施: Traditional therapy (Drug)
结局指标
主要结局
Rate of death yearly
时间窗: a year
Rate of death in a year.
Rate of death weekly
时间窗: a week
Rate of death in a week.
Survival rate yearly
时间窗: a year
Survival rate in a year.
Rate of death monthly
时间窗: a month
Rate of death in a month.
次要结局
- Number of Participants with Kidney dysfunction(a week, a month, a year)