Back to resultsAssessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity
Primary Purpose
Pesticide Poisoning
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Lipid Emulsion, Intravenous
Atropine
Toxogonin
Sodium Bicarbonate Powder and ondansetron
Sponsored by
About this trial
This is an interventional supportive care trial for Pesticide Poisoning
Eligibility Criteria
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
Sites / Locations
- Poison Control Center of Ain-Shams University hospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
control group
case group
Arm Description
will receive the traditional supportive treatment according to (PCC-ASUH) protocol
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
Outcomes
Primary Outcome Measures
mortality rate reduction
the primary end point is to lower the mortality rate for patients poisoned with pesticides
organ damage reduction
another primary end point is to reduce organ damage and injury for survivors
Secondary Outcome Measures
Full Information
NCT ID
NCT05006638
First Posted
August 8, 2021
Last Updated
August 14, 2022
Sponsor
Aya Sabry Mohamed Mohamed
1. Study Identification
Unique Protocol Identification Number
NCT05006638
Brief Title
Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aya Sabry Mohamed Mohamed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pesticide Poisoning
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
will receive the traditional supportive treatment according to (PCC-ASUH) protocol
Arm Title
case group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lipid Emulsion, Intravenous
Intervention Description
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
Intervention Name(s)
Atropine
Intervention Description
a drug used as an antidote for some types of pesticides
Intervention Type
Drug
Intervention Name(s)
Toxogonin
Intervention Description
a drug used as an antidote for some types of pesticides
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate Powder and ondansetron
Intervention Description
standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide
Primary Outcome Measure Information:
Title
mortality rate reduction
Description
the primary end point is to lower the mortality rate for patients poisoned with pesticides
Time Frame
1 year
Title
organ damage reduction
Description
another primary end point is to reduce organ damage and injury for survivors
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Sabry Mohamed
Phone
+201013910938
Email
dr.ayasabry@gmail.com
Facility Information:
Facility Name
Poison Control Center of Ain-Shams University hospitals
City
Cairo
State/Province
Abbasya
ZIP/Postal Code
11311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aya Sabry Mohamed
Phone
+201013910938
Email
dr.ayasabry@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity
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