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Clinical trial

Role of Intralipid in Management of Organophosphorus Poisoning

ID
Name
AssiutU_HAA_OP_poisoning
Description
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.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-11-01
Trial end
2026-01-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Intralipid, 20% Intravenous Emulsion
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.
Arms:
intralipid 20% adjuvant
Other names:
lipofundin 20
Intravenous Atropine Sulfate
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.
Arms:
Follow up, intralipid 20% adjuvant
Other names:
Atropine 1 mg / 1 ml
Size
60
Primary endpoint
duration in days of hospitalization and ICU stay
four days
Eligibility criteria
Inclusion Criteria: * 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). Exclusion Criteria: 1. Patient or relative in charge refusal. 2. Chronic renal or liver disease manifested by history, clinical and investigatory diagnosis. 3. Previous history of acute or chronic pancreatitis 4. Combined poisoning with non OP compounds 5. Asymptomatic patients. 6. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-07-25

1 organization

2 products

1 indication

Organization
Amani Hassan Abdel-Wahab
Product
Intralipid
Indication
Organophosphorus Poisoning
Product
Atropine Sulfate