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

Pesticide Poisoning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006638
• Other study ID #: MD27/2021
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Ain Shams University
• Contact: Aya Sabry Mohamed
• Phone: +201013910938
• Email: dr.ayasabry[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pesticide Poisoning
• Poisoning

Intervention

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
• Atropine
a drug used as an antidote for some types of pesticides
• Toxogonin
a drug used as an antidote for some types of pesticides
• Sodium Bicarbonate Powder and ondansetron
standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide

Locations

Country	Name	City	State
Egypt	Poison Control Center of Ain-Shams University hospitals	Cairo	Abbasya

Sponsors (1)

Lead Sponsor	Collaborator
Aya Sabry Mohamed Mohamed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rate reduction	the primary end point is to lower the mortality rate for patients poisoned with pesticides	1 year
Primary	organ damage reduction	another primary end point is to reduce organ damage and injury for survivors	1 year