Low Dose Euthyrox in Treatments of Paraquat Intoxication.

NCT ID: NCT04132622

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Paraquat Poisoning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental therapy group

Besides Traditional therapy，patients in this group will also receive thyroid replacement therapy.

Group Type: EXPERIMENTAL

Levothyroxine Sodium

Intervention Type: DRUG

Levothyroxine Sodium Tablets (50 ug, calculated by Levothyroxine Sodium ), produced by Merck KGaA, Darmstadt.

Traditional therapy

Intervention Type: DRUG

including steroids, vitamin C, hemodialysis and blood perfusion.

Traditional therapy group

Patients in Standard therapy group will receive treatments according to guideline worldwide.

Group Type: SHAM_COMPARATOR

Traditional therapy

Intervention Type: DRUG

including steroids, vitamin C, hemodialysis and blood perfusion.

Interventions

Levothyroxine Sodium

Levothyroxine Sodium Tablets (50 ug, calculated by Levothyroxine Sodium ), produced by Merck KGaA, Darmstadt.

Intervention Type: DRUG

Traditional therapy

including steroids, vitamin C, hemodialysis and blood perfusion.

Intervention Type: DRUG

Other Intervention Names

Euthyrox, H20140052; Standard treatment

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

Zhejiang Provincial Hospital of TCM

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuemei Chen, doctor

Role: STUDY_CHAIR

Second Affiliated Hospital of Zhejiang University School of Medicine

Central Contacts

Yuemei Chen, doctor

Role: CONTACT

324347@zju.edu.cn

+86 18758120192

Xiu Yang, master

Role: CONTACT

+86 13732221703

References

Hwang KY, Lee EY, Hong SY. Paraquat intoxication in Korea. Arch Environ Health. 2002 Mar-Apr;57(2):162-6. doi: 10.1080/00039890209602931.

Reference Type: BACKGROUND

PMID: 12194161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19721862 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2198050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18987262 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18161502 (View on PubMed)

Other Identifiers

CYM2019

Identifier Type: -

Identifier Source: org_study_id