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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pesticide Poisoning
• Intervention / Treatment: Drug: Sodium Bicarbonate Powder and ondansetron; Drug: Atropine; Drug: Toxogonin; Drug: Lipid Emulsion, Intravenous

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aya Sabry Mohamed; Phone Number: +201013910938; Email: dr.ayasabry@gmail.com

Study Locations

• Egypt
  • Abbasya
    • Cairo, Abbasya, Egypt, 11311
      • Recruiting
      • Poison Control Center of Ain-Shams University hospitals
      • Contact: Aya Sabry Mohamed; Phone Number: +201013910938; Email: dr.ayasabry@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; will receive the traditional supportive treatment according to (PCC-ASUH) protocol	Drug: Sodium Bicarbonate Powder and ondansetron; standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide; Drug: Atropine; a drug used as an antidote for some types of pesticides; Drug: Toxogonin; a drug used as an antidote for some types of pesticides
Active Comparator: case group; 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: Sodium Bicarbonate Powder and ondansetron; standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide; Drug: Atropine; a drug used as an antidote for some types of pesticides; Drug: Toxogonin; a drug used as an antidote for some types of pesticides; Drug: Lipid Emulsion, Intravenous; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aya Sabry Mohamed Mohamed

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 8, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Adjuvants, Anesthesia; Anti-Anxiety Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antipruritics; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Mydriatics; Cholinesterase Reactivators; Enzyme Reactivators; Atropine; Ondansetron; Fat Emulsions, Intravenous; Obidoxime Chloride
• Other Study ID Numbers: MD27/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No