Pesticide PoisoningPhase 4NCT05006638
Assessing The Role Of Intravenous Lipid Emulsion As A Life Saving Therapy In Pesticides Toxicity
A Phase 4 study testing Lipid Emulsion, Intravenous, Atropine and Toxogonin in people with Pesticide Poisoning, run by Aya Sabry Mohamed Mohamed at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pesticide Poisoning
- What is being tested?
- Lipid Emulsion, Intravenous, Atropine and Toxogonin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute pesticide intoxications with poison severity score 2 or 3 admitted in ICU of PCC-ASUH
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Poison Control Center of Ain-Shams University hospitals
Cairo, Abbasya, 11311
Aya Sabry Mohamed, +201013910938, dr.ayasabry@gmail.com
About this study
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
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.
- Conditions
- Pesticide Poisoning
- Being tested
- Lipid Emulsion, Intravenous, Atropine, Toxogonin, Sodium Bicarbonate Powder and ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid Emulsion, IntravenousDrug
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
AtropineDrug
a drug used as an antidote for some types of pesticides
ToxogoninDrug
a drug used as an antidote for some types of pesticides
Sodium Bicarbonate Powder and ondansetronDrug
standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | will receive the traditional supportive treatment according to (PCC-ASUH) protocol Receives: Drug: Atropine; Drug: Toxogonin; Drug: Sodium Bicarbonate Powder and ondansetron |
| case group | Active comparator | 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 Receives: Drug: Lipid Emulsion, Intravenous; Drug: Atropine; Drug: Toxogonin; Drug: Sodium Bicarbonate Powder and ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate reduction
the primary end point is to lower the mortality rate for patients poisoned with pesticides
Measured: 1 year
organ damage reduction
another primary end point is to reduce organ damage and injury for survivors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study startDec 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pesticide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aya Sabry Mohamed Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Sabry Mohamed Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006638
- Sponsor's protocol ID
- MD27/2021
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05006638
- Acronym / sponsor ID
- MD27/2021
- Conditions
- Pesticide Poisoning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Aya Sabry Mohamed MohamedUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Atropine, Drug: Toxogonin, Drug: Sodium Bicarbonate Powder and ondansetronwill receive the traditional supportive treatment according to (PCC-ASUH) protocol |
| case group | Active comparator | Drug: Lipid Emulsion, Intravenous, Drug: Atropine, Drug: Toxogonin, Drug: Sodium Bicarbonate Powder and ondansetronwill 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute pesticide intoxications with poison severity score 2 or 3 admitted in ICU of PCC-ASUH
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid Emulsion, IntravenousLipid 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 | case group |
| Atropinea drug used as an antidote for some types of pesticides | Drug | case group, control group |
| Toxogonina drug used as an antidote for some types of pesticides | Drug | case group, control group |
| Sodium Bicarbonate Powder and ondansetronstandard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide | Drug | case group, control group |
Primary outcome
mortality rate reduction
Time frame: 1 year
the primary end point is to lower the mortality rate for patients poisoned with pesticides
organ damage reduction
Time frame: 1 year
another primary end point is to reduce organ damage and injury for survivors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipid Emulsion, Intravenous, Atropine and Toxogonin in people with Pesticide Poisoning, run by Aya Sabry Mohamed Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Sabry Mohamed (+201013910938, dr.ayasabry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate reduction (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.