Clinical trial NCT04132622: Low Dose Euthyrox in Treatments of Paraquat Intoxication.
Official title: Low Dose Euthyrox in Treatments of Paraquat Intoxication: a Randomized, Controlled, Multicenter Trial in China.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Paraquat Poisoning
Keywords: Euthyrox
Paraquat Intoxication
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Hangzhou
name: Zhejiang Provincial Hospital of TCM
First posted: 2019-10-21
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of death weekly
timeFrame: a week
measure: Rate of death monthly
timeFrame: a month
measure: Rate of death yearly
timeFrame: a year
measure: Survival rate yearly
timeFrame: a year
Secondary outcomes:
measure: Number of Participants with Kidney dysfunction
timeFrame: a week, a month, a year
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Yuemei Chen, doctor
role: STUDY_CHAIR
References:
citation: Hwang KY, Lee EY, Hong SY. Paraquat intoxication in Korea. Arch Environ Health. 2002 Mar-Apr;57(2):162-6. doi: 10.1080/00039890209602931.
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.
citation: 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. doi: 10.2165/00002018-199005040-00002.
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.
citation: Dinis-Oliveira RJ, Duarte JA, Sanchez-Navarro A, Remiao F, Bastos ML, Carvalho F. Paraquat poisonings: mechanisms of lung toxicity, clinical features, and treatment. Crit Rev Toxicol. 2008;38(1):13-71. doi: 10.1080/10408440701669959.