Organophosphorus PoisoningPhase 2/3NCT04393103
Role of Intralipid in Management of Organophosphorus Poisoning
A Phase 2/3 study testing Intralipid, 20% Intravenous Emulsion and Intravenous Atropine Sulfate in people with Organophosphorus Poisoning, run by Amani Hassan Abdel-Wahab.
Trial summary
Aim of the study: To assess the role of intralipid emulsion in the acute man-agement of organophosphorus toxicity and its benefits in de-creasing mortality rates among victims. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Organophosphorus Poisoning
- What is being tested?
- Intralipid, 20% Intravenous Emulsion and Intravenous Atropine Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Jan 2025
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group of 18-60 years who are exposed to organophosphorus compounds.
- Clinical manifestations of organophosphorus toxidromes (hyper-salivation, lacrimation, sweating, urinary incontinence, di-arrhea, vomiting and abdominal pain).
Who cannot join
- Patient or relative in charge refusal.
- Chronic renal or liver disease manifested by history, clinical and investigatory diagnosis.
- Previous history of acute or chronic pancreatitis
- Combined poisoning with non OP compounds
- Asymptomatic patients.
- Contraindications to intralipid emulsion as:
- disturbances of normal fat metabolism such as patho-logic hyperlipemia manifested by history, clinical and investigatory diagnosis.
- lipoid nephrosis manifested by history, clinical and investigatory diagnosis.
About this study
Aim of the study:
To assess the role of intralipid emulsion in the acute man-agement of organophosphorus toxicity and its benefits in de-creasing mortality rates among victims.
Read the detailed description
Organophosphates (OPs) are cholinesterase inhibitors that are widely used as pesticides and organophosphate (OP) poisoning is an important public health concern in Egypt especially in the rural farming population. Organophosphate toxicity lead to a characteristic toxidrome that includes muscarinic, nicotinic and central nervous system signs and symptoms and, without proper and early antidotal treatment, death. A new antidote is the need of the hour. Lipid emulsion being inexpensive, easily available and effective in management of other lipid soluble toxins may be a novel option. The exact mechanisms by which ILE exert their beneficial effects are not fully understood, and several have suggested synergistic effects of several mechanisms. The mechanisms of action can be divided into intravascular, membrane, and intracellular effects. The original theory explaining the mechanism of lipid rescue was that of "lipid sink", suggesting sequestration of lipophilic compounds to an expanded intravascular lipid phase, extracting the offending agent from the target tissue, and reversing the toxicity. Other hypotheses relate to the mechanism by which ILEs facilitate cardiac rescue from drug poisoning. These include:
- increasing myocardial energy substrate delivery and a direct cardiotonic effect of ILE on the poisoned heart.
- an effect of ILE on calcium ion channels through high levels of long-chain fatty acids, leading to increased cardiomyocyte calcium and positive inotropic effect.
- Conditions
- Organophosphorus Poisoning
- Being tested
- Intralipid, 20% Intravenous Emulsion, Intravenous Atropine Sulfate
- Keywords
- intralipid, organophosphorus poisoning
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid, 20% Intravenous EmulsionDrug
Also called lipofundin 20
Atropine will be administered to ALL PATIENTS by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till com-plete atropinization. Following this an infusion of 10-20% of the atropinizing dose was given every hour.
- Group A (Control Group) : Follow Up of 30 patients.
- Group B (Study Group): 30 patients will receive intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart.
Intravenous Atropine SulfateDrug
Also called Atropine 1 mg / 1 ml
Atropine will be administered to ALL PATIENTS in Group A and group B by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till complete atropinization. Following this, an infusion of 10-20% of the atropinizing dose was given every hour.
| Study group | Role | What they receive |
|---|---|---|
| Follow up | Other | Follow Up of 30 patients after administration of atropine. Receives: Drug: Intravenous Atropine Sulfate |
| intralipid 20% adjuvant | Experimental | 30 patients will receive atropine and intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart. Receives: Drug: Intralipid, 20% Intravenous Emulsion; Drug: Intravenous Atropine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration in days of hospitalization and ICU stay
The primary outcome is to study the difference in total days of hospitalization and ICU stay between the study and control groups.
Measured: four days
Secondary outcomes (1)
mortality.
Death among cases under study.
Measured: four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Apr 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Why it stopped: no avilable resorces
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organophosphorus 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Atropine will be administered to ALL PATIENTS by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till com-plete atropinization. Following this an infusion of 10-20% of the atropinizing dose was given every hour.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amani Hassan Abdel-Wahab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amani Hassan Abdel-Wahab, Assiut University
- Investigators
- Hamdy A. Youssef, Professor, Study director, Professor of anesthesia and intensive care, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393103
- Sponsor's protocol ID
- AssiutU_HAA_OP_poisoning
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2020
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intralipid in Management of Organophosphorus Poisoning
- ClinicalTrials.gov ID
- NCT04393103
- Acronym / sponsor ID
- AssiutU_HAA_OP_poisoning
- Conditions
- Organophosphorus Poisoning
- Keywords
- intralipid, organophosphorus poisoning
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no avilable resorces
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Amani Hassan Abdel-WahabUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 May 2020 (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.
Aim of the study:
To assess the role of intralipid emulsion in the acute man-agement of organophosphorus toxicity and its benefits in de-creasing mortality rates among victims.
Detailed description
Organophosphates (OPs) are cholinesterase inhibitors that are widely used as pesticides and organophosphate (OP) poisoning is an important public health concern in Egypt especially in the rural farming population. Organophosphate toxicity lead to a characteristic toxidrome that includes muscarinic, nicotinic and central nervous system signs and symptoms and, without proper and early antidotal treatment, death. A new antidote is the need of the hour. Lipid emulsion being inexpensive, easily available and effective in management of other lipid soluble toxins may be a novel option. The exact mechanisms by which ILE exert their beneficial effects are not fully understood, and several have suggested synergistic effects of several mechanisms. The mechanisms of action can be divided into intravascular, membrane, and intracellular effects. The original theory explaining the mechanism of lipid rescue was that of "lipid sink", suggesting sequestration of lipophilic compounds to an expanded intravascular lipid phase, extracting the offending agent from the target tissue, and reversing the toxicity. Other hypotheses relate to the mechanism by which ILEs facilitate cardiac rescue from drug poisoning. These include:
- increasing myocardial energy substrate delivery and a direct cardiotonic effect of ILE on the poisoned heart.
- an effect of ILE on calcium ion channels through high levels of long-chain fatty acids, leading to increased cardiomyocyte calcium and positive inotropic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Atropine will be administered to ALL PATIENTS by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till com-plete atropinization. Following this an infusion of 10-20% of the atropinizing dose was given every hour.
| Arm | Type | Receives |
|---|---|---|
| Follow up | Other | Drug: Intravenous Atropine SulfateFollow Up of 30 patients after administration of atropine. |
| intralipid 20% adjuvant | Experimental | Drug: Intralipid, 20% Intravenous Emulsion, Drug: Intravenous Atropine Sulfate30 patients will receive atropine and intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age group of 18-60 years who are exposed to organophosphorus compounds.
- Clinical manifestations of organophosphorus toxidromes (hyper-salivation, lacrimation, sweating, urinary incontinence, di-arrhea, vomiting and abdominal pain).
Key exclusion criteria (8 listed)
- Patient or relative in charge refusal.
- Chronic renal or liver disease manifested by history, clinical and investigatory diagnosis.
- Previous history of acute or chronic pancreatitis
- Combined poisoning with non OP compounds
- Asymptomatic patients.
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 |
|---|---|---|
| Intralipid, 20% Intravenous EmulsionAlso: lipofundin 20Atropine will be administered to ALL PATIENTS by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till com-plete atropinization. Following this an infusion of 10-20% of the atropinizing dose was given every hour. * Group A (Control Group) : Follow Up of 30 patients. * Group B (Study Group): 30 patients will receive intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart. | Drug | intralipid 20% adjuvant |
| Intravenous Atropine SulfateAlso: Atropine 1 mg / 1 mlAtropine will be administered to ALL PATIENTS in Group A and group B by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till complete atropinization. Following this, an infusion of 10-20% of the atropinizing dose was given every hour. | Drug | Follow up, intralipid 20% adjuvant |
Primary outcome
duration in days of hospitalization and ICU stay
Time frame: four days
The primary outcome is to study the difference in total days of hospitalization and ICU stay between the study and control groups.
1 secondary outcome
mortality.
Time frame: four days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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.
Hamdy A. Youssef, Professor study director
Professor of anesthesia and intensive care, Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intralipid, 20% Intravenous Emulsion and Intravenous Atropine Sulfate in people with Organophosphorus Poisoning, run by Amani Hassan Abdel-Wahab.
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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration in days of hospitalization and ICU stay (time frame: four days). 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 3 Oct 2025.