Role of Intralipid in Management of Organophosphorus Poisoning

NCT04393103 | Withdrawn Phase 2

• 1 other identifier: AssiutU_HAA_OP_poisoning
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Organophosphorus Poisoning

Keywords

intralipid, organophosphorus poisoning

Outcome Measures

Primary Outcomes (1)

• 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.

  four days

Secondary Outcomes (1)

• mortality.

  four days

Study Arms (2)

Follow up

OTHER

Follow Up of 30 patients after administration of atropine.

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.

Drug: Intralipid, 20% Intravenous Emulsion; Drug: Intravenous Atropine Sulfate

Interventions

Intralipid, 20% Intravenous Emulsion DRUG

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.

Also known as: lipofundin 20

intralipid 20% adjuvant

Intravenous Atropine Sulfate DRUG

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.

Also known as: Atropine 1 mg / 1 ml

Follow up; intralipid 20% adjuvant

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amani Hassan Abdel-Wahab: lead

MeSH Terms

Conditions

Organophosphate Poisoning

Interventions

soybean oil, phospholipid emulsion; Atropine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Hamdy A. Youssef, Professor

  Professor of anesthesia and intensive care, Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of anesthesia and intensive care

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 19, 2020
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share