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Role of Intralipid in Management of Organophosphorus Poisoning

A

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)

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

Trial contacts and locations

0

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Central trial contact

Ahmad Hashem Sleem

Data sourced from clinicaltrials.gov

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