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

NCT05006638 | Unknown Phase 4

• 1 other identifier: MD27/2021
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pesticide Poisoning

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

control group

PLACEBO COMPARATOR

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

Drug: Atropine; Drug: Toxogonin; Drug: Sodium Bicarbonate Powder and ondansetron

case group

ACTIVE COMPARATOR

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; Drug: Atropine; Drug: Toxogonin; Drug: Sodium Bicarbonate Powder and ondansetron

Interventions

Lipid Emulsion, Intravenous DRUG

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

case group

Atropine DRUG

a drug used as an antidote for some types of pesticides

case group; control group

Toxogonin DRUG

a drug used as an antidote for some types of pesticides

case group; control group

Sodium Bicarbonate Powder and ondansetron DRUG

standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide

case group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aya Sabry Mohamed Mohamed: lead

Study Sites (1)

Poison Control Center of Ain-Shams University hospitals

Cairo, Abbasya, 11311, Egypt

RECRUITING

MeSH Terms

Interventions

Fat Emulsions, Intravenous; Atropine; Obidoxime Chloride; Ondansetron

Intervention Hierarchy (Ancestors)

Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Oximes; Hydroxylamines; Amines; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Aya Sabry Mohamed

CONTACT

+201013910938; dr.ayasabry@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of forensic medicine and clinical toxicology department faculty of medicine Ain shams university

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 16, 2021
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

EG (1)