LDETPI: Low Dose Euthyrox in Treatments of Paraquat Intoxication.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental therapy group Besides Traditional therapy，patients in this group will also receive thyroid replacement therapy. |
Drug: Levothyroxine Sodium
Levothyroxine Sodium Tablets (50 ug, calculated by Levothyroxine Sodium ), produced by Merck KGaA, Darmstadt.
Other Names:
Drug: Traditional therapy
including steroids, vitamin C, hemodialysis and blood perfusion.
Other Names:
|
| Sham Comparator: Traditional therapy group Patients in Standard therapy group will receive treatments according to guideline worldwide. |
Drug: Traditional therapy
including steroids, vitamin C, hemodialysis and blood perfusion.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of death weekly [a week]
Rate of death in a week.
- Rate of death monthly [a month]
Rate of death in a month.
- Rate of death yearly [a year]
Rate of death in a year.
- Survival rate yearly [a year]
Survival rate in a year.
Secondary Outcome Measures
- Number of Participants with Kidney dysfunction [a week, a month, a year]
Number of Participants with Kidney dysfunction with paraquat poisoning
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- First People's Hospital of Hangzhou
- Zhejiang Provincial Hospital of TCM
Investigators
- Study Chair: Yuemei Chen, doctor, Second Affiliated Hospital of Zhejiang University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Bismuth C, Garnier R, Baud FJ, Muszynski J, Keyes C. Paraquat poisoning. An overview of the current status. Drug Saf. 1990 Jul-Aug;5(4):243-51. Review.
- Dinis-Oliveira RJ, Duarte JA, Sánchez-Navarro A, Remião F, Bastos ML, Carvalho F. Paraquat poisonings: mechanisms of lung toxicity, clinical features, and treatment. Crit Rev Toxicol. 2008;38(1):13-71. Review.
- Hwang KY, Lee EY, Hong SY. Paraquat intoxication in Korea. Arch Environ Health. 2002 Mar-Apr;57(2):162-6.
- Kim SJ, Gil HW, Yang JO, Lee EY, Hong SY. The clinical features of acute kidney injury in patients with acute paraquat intoxication. Nephrol Dial Transplant. 2009 Apr;24(4):1226-32. doi: 10.1093/ndt/gfn615. Epub 2008 Nov 5.
- Seok SJ, Gil HW, Jeong DS, Yang JO, Lee EY, Hong SY. Paraquat intoxication in subjects who attempt suicide: why they chose paraquat. Korean J Intern Med. 2009 Sep;24(3):247-51. doi: 10.3904/kjim.2009.24.3.247. Epub 2009 Aug 26.
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