Low Dose Euthyrox in Treatments of Paraquat Intoxication. (LDETPI)

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Paraquat Poisoning

Treatments: Drug: Traditional therapy; Drug: Levothyroxine Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT04132622

CYM2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Experimental therapy group

Experimental group

Description:

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

Treatment:

Drug: Traditional therapy

Drug: Levothyroxine Sodium

Traditional therapy group

Sham Comparator group

Description:

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

Treatment:

Drug: Traditional therapy