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Supportive Measures in Treatment of Aluminum Phosphide Poisoning

Primary Purpose

Detection of Different Prognostic Factors and Their Relation With the Outcome, Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
N-acetyl cysteine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Detection of Different Prognostic Factors and Their Relation With the Outcome focused on measuring Aluminum phosphide, N-acetylcystein, Assiut, prognostic factors

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All the cases with the primary diagnosis of Aluminum phosphide toxicity will be included in the study.
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

  • Patients with a history of any chronic disease (renal and hepatic).
  • Patients refuse to participate in the study.
  • Aged less than 18 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Aluminum phosphide patients

    Arm Description

    effect of N-acetyl cysteine and supportive measures in outcome of aluminum phosphide poisoning cases

    Outcomes

    Primary Outcome Measures

    mortality rate comparison
    comparison of mortality rate using the New protocol and previous mortality rate from archive records
    hospital stay
    number of days the patient stayed at hospital

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2019
    Last Updated
    March 15, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03879356
    Brief Title
    Supportive Measures in Treatment of Aluminum Phosphide Poisoning
    Official Title
    Supportive Measures in Treatment of Aluminum Phosphide Poisoning as a Trial to Reduce Mortality at Assiut University Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    June 30, 2016 (Actual)
    Study Completion Date
    March 14, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aluminum phosphide poisoning (ALP) is a global public health problem, and self-poisoning accounts for one-third of the world's suicide rate. In fact, in some parts of developing countries, pesticide poisoning causes more deaths than infection. ALP is very common in our government and the prognosis of the cases is usually so bad. Toxicity by ALP is caused by the liberation of phosphine gas, which causes cell hypoxia due to inhibition of oxidative phosphorylation leading to circulatory failure.
    Detailed Description
    Aluminum phosphide poisoning is a major problem, accounting for many Emergency Unit visits and hospitalization, the incidence of aluminum phosphide poisoning increasing in the last few years. ALP is used as pesticides for many years to protect grains in stores and during its transportation. The availability of these tablets and their low cost make it an easy and common method of suicide in our country with the increasing incidence of social and financial problems that face the youth. In management, the main objective is to provide effective oxygenation, ventilation, and circulation until phosphine is excreted. All patients of severe ALP poisoning require continuous invasive hemodynamic monitoring and early resuscitation with fluid and vasoactive agents. N- acetylcysteine as an antioxidant and cytoprotective agent reduces myocardial oxidative injury and increase survival time. Magnesium sulfate helps in scavenging free radicals through glutathione (GSH) recovery hence is effective as a parenteral antioxidant in this poisoning as well as has been tried for its general membrane stabilizing effect in cardiac cells . Death after 24 hours occurs usually owing to shock, cardiac arrhythmia, metabolic acidosis, and acute respiratory distress syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Detection of Different Prognostic Factors and Their Relation With the Outcome, Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning
    Keywords
    Aluminum phosphide, N-acetylcystein, Assiut, prognostic factors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aluminum phosphide patients
    Arm Type
    Other
    Arm Description
    effect of N-acetyl cysteine and supportive measures in outcome of aluminum phosphide poisoning cases
    Intervention Type
    Drug
    Intervention Name(s)
    N-acetyl cysteine
    Intervention Description
    effect of N-acetyl cysteine in Aluminum phosphide poisoning patients
    Primary Outcome Measure Information:
    Title
    mortality rate comparison
    Description
    comparison of mortality rate using the New protocol and previous mortality rate from archive records
    Time Frame
    3 days
    Title
    hospital stay
    Description
    number of days the patient stayed at hospital
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All the cases with the primary diagnosis of Aluminum phosphide toxicity will be included in the study. Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: Patients with a history of any chronic disease (renal and hepatic). Patients refuse to participate in the study. Aged less than 18 years

    12. IPD Sharing Statement

    Learn more about this trial

    Supportive Measures in Treatment of Aluminum Phosphide Poisoning

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