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

NCT ID: NCT05006638

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Pesticide Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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control group

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

Group Type PLACEBO_COMPARATOR

Atropine

Intervention Type DRUG

a drug used as an antidote for some types of pesticides

Toxogonin

Intervention Type DRUG

a drug used as an antidote for some types of pesticides

Sodium Bicarbonate Powder and ondansetron

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Lipid Emulsion, Intravenous

Intervention Type 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

Atropine

Intervention Type DRUG

a drug used as an antidote for some types of pesticides

Toxogonin

Intervention Type DRUG

a drug used as an antidote for some types of pesticides

Sodium Bicarbonate Powder and ondansetron

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Atropine

a drug used as an antidote for some types of pesticides

Intervention Type DRUG

Toxogonin

a drug used as an antidote for some types of pesticides

Intervention Type DRUG

Sodium Bicarbonate Powder and ondansetron

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aya Sabry Mohamed Mohamed

OTHER

Sponsor Role lead

Responsible Party

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Aya Sabry Mohamed Mohamed

Assistant lecturer of forensic medicine and clinical toxicology department faculty of medicine Ain shams university

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Poison Control Center of Ain-Shams University hospitals

Cairo, Abbasya, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aya Sabry Mohamed

Role: CONTACT

+201013910938

Facility Contacts

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Aya Sabry Mohamed

Role: primary

+201013910938

Other Identifiers

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MD27/2021

Identifier Type: -

Identifier Source: org_study_id

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