Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity
Phase 4
- Conditions
- Pesticide Poisoning
- Interventions
- Drug: Lipid Emulsion, Intravenous
- Registration Number
- NCT05006638
- Lead Sponsor
- Aya Sabry Mohamed Mohamed
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 62
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group Toxogonin will receive the traditional supportive treatment according to (PCC-ASUH) protocol case group Lipid Emulsion, Intravenous 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 case group Toxogonin 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 case group Sodium Bicarbonate Powder and ondansetron 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 control group Sodium Bicarbonate Powder and ondansetron will receive the traditional supportive treatment according to (PCC-ASUH) protocol control group Atropine will receive the traditional supportive treatment according to (PCC-ASUH) protocol case group Atropine 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
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Poison Control Center of Ain-Shams University hospitals
🇪🇬Cairo, Abbasya, Egypt