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

Study Overview
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Brief Summary
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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.

Official Title
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Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity: A Randomized Controlled Trial In Poison Control Center Of Ain Shams University Hospitals

Conditions
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Pesticide Poisoning

Intervention / Treatment
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* Drug: Lipid Emulsion, Intravenous
* Drug: Atropine
* Drug: Toxogonin
* Drug: Sodium Bicarbonate Powder and ondansetron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>will receive the traditional supportive treatment according to (PCC-ASUH) protocol | Drug: Atropine<br>* a drug used as an antidote for some types of pesticides<br>Drug: Toxogonin<br>* a drug used as an antidote for some types of pesticides<br>Drug: Sodium Bicarbonate Powder and ondansetron<br>* standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide<br>|
| Active Comparator: case group<br>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 | Drug: Lipid Emulsion, Intravenous<br>* Lipid emulsion is a mixture of soybean oil, egg phospholipids, glycerine, and is available in 10%, 20%, and 30% strengths. It has been used for decades as parenteral nutrition and for caloric supplementation and essential fatty acid deficiency. It has also been used as a carrier for lipid soluble medications<br>Drug: Atropine<br>* a drug used as an antidote for some types of pesticides<br>Drug: Toxogonin<br>* a drug used as an antidote for some types of pesticides<br>Drug: Sodium Bicarbonate Powder and ondansetron<br>* standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate reduction | the primary end point is to lower the mortality rate for patients poisoned with pesticides | 1 year | 
| organ damage reduction | another primary end point is to reduce organ damage and injury for survivors | 1 year |