Role of Intralipid in Management of Organophosphorus Poisoning

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.

Study Overview

• Status: Withdrawn
• Conditions: Organophosphorus Poisoning
• Intervention / Treatment: Drug: Intravenous Atropine Sulfate; Drug: Intralipid, 20% Intravenous Emulsion

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:

1. increasing myocardial energy substrate delivery and a direct cardiotonic effect of ILE on the poisoned heart.
2. 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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Follow up; Follow Up of 30 patients after administration of atropine.	Drug: Intravenous Atropine Sulfate; 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.; Other Names: Atropine 1 mg / 1 ml
Experimental: intralipid 20% adjuvant; 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.	Drug: Intravenous Atropine Sulfate; 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.; Other Names: Atropine 1 mg / 1 ml; Drug: Intralipid, 20% Intravenous Emulsion; 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.; Other Names: lipofundin 20

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	four days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality.	Death among cases under study.	four days

Collaborators and Investigators

• Sponsor: Amani Hassan Abdel-Wahab
• Investigators: Study Director: Hamdy A. Youssef, Professor, Professor of anesthesia and intensive care, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: intralipid, organophosphorus poisoning
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Organophosphate Poisoning; Organic Chemicals; Heterocyclic Compounds; Alkaloids; Aza Compounds; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Atropine; soybean oil, phospholipid emulsion
• Other Study ID Numbers: AssiutU_HAA_OP_poisoning

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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