Low Dose Euthyrox in Treatments of Paraquat Intoxication.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low Dose Euthyrox in Treatments of Paraquat Intoxication: a Randomized, Controlled, Multicenter Trial in China.

Conditions
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Paraquat Poisoning

Intervention / Treatment
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* Drug: Levothyroxine Sodium
* Drug: Traditional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all the patients who are diagnosed by paraquat poisoning Exclusion Criteria: patients who can not cooperate with the trial; patients who would not like to join in the trial.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental therapy group<br>Besides Traditional therapy，patients in this group will also receive thyroid replacement therapy. | Drug: Levothyroxine Sodium<br>* Levothyroxine Sodium Tablets (50 ug, calculated by Levothyroxine Sodium ), produced by Merck KGaA, Darmstadt.<br>* Other names: Euthyrox, H20140052;Drug: Traditional therapy<br>* including steroids, vitamin C, hemodialysis and blood perfusion.<br>* Other names: Standard treatment;|
| Sham Comparator: Traditional therapy group<br>Patients in Standard therapy group will receive treatments according to guideline worldwide. | Drug: Traditional therapy<br>* including steroids, vitamin C, hemodialysis and blood perfusion.<br>* Other names: Standard treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of death weekly | Rate of death in a week. | a week | 
| Rate of death monthly | Rate of death in a month. | a month | 
| Rate of death yearly | Rate of death in a year. | a year | 
| Survival rate yearly | Survival rate in a year. | a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Kidney dysfunction | Number of Participants with Kidney dysfunction with paraquat poisoning | a week, a month, a year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Euthyrox, Paraquat Intoxication