Clinical trial NCT04393103: Role of Intralipid in Management of Organophosphorus Poisoning
Official title: Role of Intralipid in Management of Organophosphorus Poisoning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Organophosphorus Poisoning
Keywords: intralipid, organophosphorus poisoning
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: duration in days of hospitalization and ICU stay
timeFrame: four days
Secondary outcomes:
measure: mortality.
timeFrame: four days
Other outcomes:
Locations:
Study officials:
affiliation: Professor of anesthesia and intensive care, Assiut University
name: Hamdy A. Youssef, Professor
role: STUDY_DIRECTOR
References: