Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity

Aya Sabry Mohamed Mohamed

Status and phase: Enrolling; Phase 4

Conditions: Pesticide Poisoning

Treatments: Drug: Toxogonin; Drug: Atropine; Drug: Sodium Bicarbonate Powder and ondansetron; Drug: Lipid Emulsion, Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT05006638

MD27/2021

Details and patient eligibility

About

Intravenous lipid emulsion is an established, effective treatment for local anesthetic systemic toxicity. It is also efficacious in animal models of severe cardiotoxicity caused by a number of other medications. Recent case reports of successful resuscitation suggest the efficacy of lipid emulsion infusion for treating non-local anesthetic overdoses across a wide spectrum of drugs. The present study will focus on the potential role of intravenous lipid emulsion as an adjuvant therapy in pesticides toxicity.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute pesticide intoxications with poison severity score 2 or 3 admitted in ICU of PCC-ASUH

Exclusion criteria

• Patients less than 18 years and more than 65 years.
• Pregnant and lactating females.
• Presence of medical diseases (e.g. renal, hepatic, cardiovascular, neurological diseases and chronic pancreatitis.)
• Allergy to soya-, egg-or peanut protein

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

will receive the traditional supportive treatment according to (PCC-ASUH) protocol

Treatment:

Drug: Atropine

Drug: Toxogonin

Drug: Sodium Bicarbonate Powder and ondansetron

case group

Active Comparator group

Description:

will receive the traditional supportive treatment plus administration of ILE (20%) 1.5 ml/kg as a bolus over 2-3 minutes. Followed immediately by an infusion of 20 % lipid emulsion at a rate of 0.25 mL/kg/min. After 3 minutes of this infusion rate, response to the bolus and initial infusion should be assessed. If there has been a significant response, the infusion rate can be adjusted to 0.025 mL/kg/min with monitoring of blood pressure, heart rate, and other available hemodynamic parameters during the infusion with a maximum dose of 10 mL/kg

Treatment:

Drug: Lipid Emulsion, Intravenous

Drug: Atropine

Drug: Toxogonin

Drug: Sodium Bicarbonate Powder and ondansetron