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