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Role of Intralipid in Management of Organophosphorus Poisoning

Primary Purpose

Organophosphorus Poisoning

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intralipid, 20% Intravenous Emulsion
Intravenous Atropine Sulfate
Sponsored by
Amani Hassan Abdel-Wahab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Organophosphorus Poisoning focused on measuring intralipid, organophosphorus poisoning

Eligibility Criteria

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

Inclusion Criteria:

  • Age group of 18-60 years who are exposed to organophosphorus compounds.
  • Clinical manifestations of organophosphorus toxidromes (hyper-salivation, lacrimation, sweating, urinary incontinence, di-arrhea, vomiting and abdominal pain).

Exclusion Criteria:

  1. Patient or relative in charge refusal.
  2. Chronic renal or liver disease manifested by history, clinical and investigatory diagnosis.
  3. Previous history of acute or chronic pancreatitis
  4. Combined poisoning with non OP compounds
  5. Asymptomatic patients.
  6. Contraindications to intralipid emulsion as:

    • disturbances of normal fat metabolism such as patho-logic hyperlipemia manifested by history, clinical and investigatory diagnosis.
    • lipoid nephrosis manifested by history, clinical and investigatory diagnosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Follow up

    intralipid 20% adjuvant

    Arm Description

    Follow Up of 30 patients after administration of atropine.

    30 patients will receive atropine and intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart.

    Outcomes

    Primary Outcome Measures

    duration in days of hospitalization and ICU stay
    The primary outcome is to study the difference in total days of hospitalization and ICU stay between the study and control groups.

    Secondary Outcome Measures

    mortality.
    Death among cases under study.

    Full Information

    First Posted
    April 27, 2020
    Last Updated
    July 24, 2023
    Sponsor
    Amani Hassan Abdel-Wahab
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04393103
    Brief Title
    Role of Intralipid in Management of Organophosphorus Poisoning
    Official Title
    Role of Intralipid in Management of Organophosphorus Poisoning
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2024 (Anticipated)
    Primary Completion Date
    November 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Amani Hassan Abdel-Wahab

    4. Oversight

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

    5. Study Description

    Brief Summary
    Aim of the study: To assess the role of intralipid emulsion in the acute man-agement of organophosphorus toxicity and its benefits in de-creasing mortality rates among victims.
    Detailed Description
    Organophosphates (OPs) are cholinesterase inhibitors that are widely used as pesticides and organophosphate (OP) poisoning is an important public health concern in Egypt especially in the rural farming population. Organophosphate toxicity lead to a characteristic toxidrome that includes muscarinic, nicotinic and central nervous system signs and symptoms and, without proper and early antidotal treatment, death. A new antidote is the need of the hour. Lipid emulsion being inexpensive, easily available and effective in management of other lipid soluble toxins may be a novel option. The exact mechanisms by which ILE exert their beneficial effects are not fully understood, and several have suggested synergistic effects of several mechanisms. The mechanisms of action can be divided into intravascular, membrane, and intracellular effects. The original theory explaining the mechanism of lipid rescue was that of "lipid sink", suggesting sequestration of lipophilic compounds to an expanded intravascular lipid phase, extracting the offending agent from the target tissue, and reversing the toxicity. Other hypotheses relate to the mechanism by which ILEs facilitate cardiac rescue from drug poisoning. These include: increasing myocardial energy substrate delivery and a direct cardiotonic effect of ILE on the poisoned heart. an effect of ILE on calcium ion channels through high levels of long-chain fatty acids, leading to increased cardiomyocyte calcium and positive inotropic effect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Organophosphorus Poisoning
    Keywords
    intralipid, organophosphorus poisoning

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Atropine will be administered to ALL PATIENTS by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till com-plete atropinization. Following this an infusion of 10-20% of the atropinizing dose was given every hour.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Follow up
    Arm Type
    Other
    Arm Description
    Follow Up of 30 patients after administration of atropine.
    Arm Title
    intralipid 20% adjuvant
    Arm Type
    Experimental
    Arm Description
    30 patients will receive atropine and intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart.
    Intervention Type
    Drug
    Intervention Name(s)
    Intralipid, 20% Intravenous Emulsion
    Other Intervention Name(s)
    lipofundin 20
    Intervention Description
    Atropine will be administered to ALL PATIENTS by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till com-plete atropinization. Following this an infusion of 10-20% of the atropinizing dose was given every hour. Group A (Control Group) : Follow Up of 30 patients. Group B (Study Group): 30 patients will receive intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Atropine Sulfate
    Other Intervention Name(s)
    Atropine 1 mg / 1 ml
    Intervention Description
    Atropine will be administered to ALL PATIENTS in Group A and group B by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till complete atropinization. Following this, an infusion of 10-20% of the atropinizing dose was given every hour.
    Primary Outcome Measure Information:
    Title
    duration in days of hospitalization and ICU stay
    Description
    The primary outcome is to study the difference in total days of hospitalization and ICU stay between the study and control groups.
    Time Frame
    four days
    Secondary Outcome Measure Information:
    Title
    mortality.
    Description
    Death among cases under study.
    Time Frame
    four 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: Age group of 18-60 years who are exposed to organophosphorus compounds. Clinical manifestations of organophosphorus toxidromes (hyper-salivation, lacrimation, sweating, urinary incontinence, di-arrhea, vomiting and abdominal pain). Exclusion Criteria: Patient or relative in charge refusal. Chronic renal or liver disease manifested by history, clinical and investigatory diagnosis. Previous history of acute or chronic pancreatitis Combined poisoning with non OP compounds Asymptomatic patients. Contraindications to intralipid emulsion as: disturbances of normal fat metabolism such as patho-logic hyperlipemia manifested by history, clinical and investigatory diagnosis. lipoid nephrosis manifested by history, clinical and investigatory diagnosis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmad Hashem Sleem
    Phone
    +201002954939
    Email
    ahmad_hs_87@med.aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamdy A. Youssef, Professor
    Organizational Affiliation
    Professor of anesthesia and intensive care, Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Role of Intralipid in Management of Organophosphorus Poisoning

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