Low Dose Euthyrox in Treatments of Paraquat Intoxication.

Paraquat Poisoning Clinical Trial

— LDETPI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04132622
• Other study ID #: CYM2019
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuemei Chen, doctor
• Phone: +86 18758120192
• Email: 324347[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Paraquat Poisoning
• Poisoning

Intervention

Drug:
• Levothyroxine Sodium
Levothyroxine Sodium Tablets (50 ug, calculated by Levothyroxine Sodium ), produced by Merck KGaA, Darmstadt.
• Traditional therapy
including steroids, vitamin C, hemodialysis and blood perfusion.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First People's Hospital of Hangzhou, Zhejiang Provincial Hospital of TCM

References & Publications (5)

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. — View Citation

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. — View Citation

Hwang KY, Lee EY, Hong SY. Paraquat intoxication in Korea. Arch Environ Health. 2002 Mar-Apr;57(2):162-6. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of death weekly	Rate of death in a week.	a week
Primary	Rate of death monthly	Rate of death in a month.	a month
Primary	Rate of death yearly	Rate of death in a year.	a year
Primary	Survival rate yearly	Survival rate in a year.	a year
Secondary	Number of Participants with Kidney dysfunction	Number of Participants with Kidney dysfunction with paraquat poisoning	a week, a month, a year