NCT04132622

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

October 17, 2019

Last Update Submit

October 19, 2019

Conditions

Paraquat Poisoning

Keywords

EuthyroxParaquat Intoxication

Outcome Measures

Primary Outcomes (4)

  • Rate of death weekly

    Rate of death in a week.

    a week

  • Rate of death monthly

    Rate of death in a month.

    a month

  • Rate of death yearly

    Rate of death in a year.

    a year

  • Survival rate yearly

    Survival rate in a year.

    a year

Secondary Outcomes (1)

  • Number of Participants with Kidney dysfunction

    a week, a month, a year

Study Arms (2)

Experimental therapy group

EXPERIMENTAL

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

Drug: Levothyroxine SodiumDrug: Traditional therapy

Traditional therapy group

SHAM COMPARATOR

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

Drug: Traditional therapy

Interventions

Levothyroxine SodiumDRUG

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

Also known as: Euthyrox, H20140052
Experimental therapy group
Traditional therapyDRUG

including steroids, vitamin C, hemodialysis and blood perfusion.

Also known as: Standard treatment
Experimental therapy groupTraditional therapy group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all the patients who are diagnosed by paraquat poisoning

You may not qualify if:

  • patients who can not cooperate with the trial; patients who would not like to join in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

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

    PMID: 12194161BACKGROUND

  • 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.

    PMID: 19721862BACKGROUND

  • 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.

    PMID: 2198050BACKGROUND

  • 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.

    PMID: 18987262BACKGROUND

  • 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.

    PMID: 18161502BACKGROUND

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Yuemei Chen, doctor

    Second Affiliated Hospital of Zhejiang University School of Medicine

    STUDY CHAIR

Central Study Contacts

Yuemei Chen, doctor

CONTACT

+86 18758120192324347@zju.edu.cn

Xiu Yang, master

CONTACT

+86 13732221703

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 21, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share