NCT04393103

Role of Intralipid in Management of Organophosphorus Poisoning

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amani Hassan Abdel-Wahab · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

• Organophosphorus Poisoning

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2020-05-19
• Last updated: 2025-10-03