Role of Intralipid in Management of Organophosphorus Poisoning

Organophosphorus Poisoning Clinical Trial

Official title:

Role of Intralipid in Management of Organophosphorus Poisoning

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04393103
• Other study ID #: AssiutU_HAA_OP_poisoning
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2024
• Est. completion date: January 2026

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Ahmad Hashem Sleem
• Phone: +201002954939
• Email: ahmad_hs_87[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Organophosphate Poisoning
• Organophosphorus Poisoning
• Poisoning

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amani Hassan Abdel-Wahab

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mortality.	Death among cases under study.	four days