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

Primary Purpose

Paraquat Poisoning

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levothyroxine Sodium
Traditional therapy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paraquat Poisoning focused on measuring Euthyrox, Paraquat Intoxication

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Experimental therapy group

    Traditional therapy group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Number of Participants with Kidney dysfunction
    Number of Participants with Kidney dysfunction with paraquat poisoning

    Full Information

    First Posted
    October 17, 2019
    Last Updated
    October 19, 2019
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    First People's Hospital of Hangzhou, Zhejiang Provincial Hospital of TCM
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04132622
    Brief Title
    Low Dose Euthyrox in Treatments of Paraquat Intoxication.
    Acronym
    LDETPI
    Official Title
    Low Dose Euthyrox in Treatments of Paraquat Intoxication: a Randomized, Controlled, Multicenter Trial in China.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    First People's Hospital of Hangzhou, Zhejiang Provincial Hospital of TCM

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Paraquat Poisoning
    Keywords
    Euthyrox, Paraquat Intoxication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental therapy group
    Arm Type
    Experimental
    Arm Description
    Besides Traditional therapy，patients in this group will also receive thyroid replacement therapy.
    Arm Title
    Traditional therapy group
    Arm Type
    Sham Comparator
    Arm Description
    Patients in Standard therapy group will receive treatments according to guideline worldwide.
    Intervention Type
    Drug
    Intervention Name(s)
    Levothyroxine Sodium
    Other Intervention Name(s)
    Euthyrox, H20140052
    Intervention Description
    Levothyroxine Sodium Tablets (50 ug, calculated by Levothyroxine Sodium ), produced by Merck KGaA, Darmstadt.
    Intervention Type
    Drug
    Intervention Name(s)
    Traditional therapy
    Other Intervention Name(s)
    Standard treatment
    Intervention Description
    including steroids, vitamin C, hemodialysis and blood perfusion.
    Primary Outcome Measure Information:
    Title
    Rate of death weekly
    Description
    Rate of death in a week.
    Time Frame
    a week
    Title
    Rate of death monthly
    Description
    Rate of death in a month.
    Time Frame
    a month
    Title
    Rate of death yearly
    Description
    Rate of death in a year.
    Time Frame
    a year
    Title
    Survival rate yearly
    Description
    Survival rate in a year.
    Time Frame
    a year
    Secondary Outcome Measure Information:
    Title
    Number of Participants with Kidney dysfunction
    Description
    Number of Participants with Kidney dysfunction with paraquat poisoning
    Time Frame
    a week, a month, a year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuemei Chen, doctor
    Phone
    +86 18758120192
    Email
    324347@zju.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiu Yang, master
    Phone
    +86 13732221703
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuemei Chen, doctor
    Organizational Affiliation
    Second Affiliated Hospital of Zhejiang University School of Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12194161
    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.
    Results Reference
    background
    PubMed Identifier
    19721862
    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.
    Results Reference
    background
    PubMed Identifier
    2198050
    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.
    Results Reference
    background
    PubMed Identifier
    18987262
    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.
    Results Reference
    background
    PubMed Identifier
    18161502
    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.
    Results Reference
    background

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    Low Dose Euthyrox in Treatments of Paraquat Intoxication.

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