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

Sponsor

Aya Sabry Mohamed Mohamed (Other)

Overall Status

Recruiting

CT.gov ID

NCT05006638

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pesticide Poisoning	Drug: Lipid Emulsion, Intravenous Drug: Atropine Drug: Toxogonin Drug: Sodium Bicarbonate Powder and ondansetron	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control group will receive the traditional supportive treatment according to (PCC-ASUH) protocol	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: Sodium Bicarbonate Powder and ondansetron standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide
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: 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 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: Sodium Bicarbonate Powder and ondansetron standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide

Arm

Intervention/Treatment

Placebo Comparator: control group

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

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: Sodium Bicarbonate Powder and ondansetron

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

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: 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

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: Sodium Bicarbonate Powder and ondansetron

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

Outcome Measures

Primary Outcome Measures

mortality rate reduction [1 year]
the primary end point is to lower the mortality rate for patients poisoned with pesticides
organ damage reduction [1 year]
another primary end point is to reduce organ damage and injury for survivors

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poison Control Center of Ain-Shams University hospitals	Cairo	Abbasya	Egypt	11311

Sponsors and Collaborators

Aya Sabry Mohamed Mohamed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Sabry Mohamed Mohamed, Assistant lecturer of forensic medicine and clinical toxicology department faculty of medicine Ain shams university, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05006638

Other Study ID Numbers: