Role of Intralipid in Management of Organophosphorus Poisoning

Amani Hassan Abdel-Wahab

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Organophosphorus Poisoning

Treatments: Drug: Intravenous Atropine Sulfate; Drug: Intralipid, 20% Intravenous Emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT04393103

AssiutU_HAA_OP_poisoning

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Follow up

Other group

Description:

Follow Up of 30 patients after administration of atropine.

Treatment:

Drug: Intravenous Atropine Sulfate

intralipid 20% adjuvant

Experimental group

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.

Treatment:

Drug: Intralipid, 20% Intravenous Emulsion

Drug: Intravenous Atropine Sulfate