Low Dose Euthyrox in Treatments of Paraquat Intoxication.

Phase 4

• Conditions: Paraquat Poisoning
• Interventions: Drug: Levothyroxine Sodium; Drug: Traditional therapy

• Registration Number: NCT04132622
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Last Update Submitted: 2019-10-19
• Study First Posted: 2019-10-21
• Last Update Posted: 2019-10-22
• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental therapy group	Traditional therapy	Besides Traditional therapy，patients in this group will also receive thyroid replacement therapy.
Traditional therapy group	Traditional therapy	Patients in Standard therapy group will receive treatments according to guideline worldwide.
Experimental therapy group	Levothyroxine Sodium	Besides Traditional therapy，patients in this group will also receive thyroid replacement therapy.

Primary Outcome Measures

Name	Time	Method
Rate of death yearly	a year	Rate of death in a year.
Rate of death weekly	a week	Rate of death in a week.
Survival rate yearly	a year	Survival rate in a year.
Rate of death monthly	a month	Rate of death in a month.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Kidney dysfunction	a week, a month, a year	Number of Participants with Kidney dysfunction with paraquat poisoning