Studies
| Study First Submitted Date | 2020-04-27 |
| Study First Posted Date | 2020-05-19 |
| Last Update Posted Date | 2023-07-25 |
| Start Month Year | April 2024 |
| Primary Completion Month Year | November 2025 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-07-25 |
Detailed Descriptions
| Sequence: | 20753861 |
| 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. |
Browse Interventions
| Sequence: | 96183435 | Sequence: | 96183436 | Sequence: | 96183437 | Sequence: | 96183438 | Sequence: | 96183439 | Sequence: | 96183440 | Sequence: | 96183441 | Sequence: | 96183442 | Sequence: | 96183443 | Sequence: | 96183444 | Sequence: | 96183445 | Sequence: | 96183446 | Sequence: | 96183447 | Sequence: | 96183448 | Sequence: | 96183449 | Sequence: | 96183450 | Sequence: | 96183451 | Sequence: | 96183452 | Sequence: | 96183453 | Sequence: | 96183454 |
| Mesh Term | Atropine | Mesh Term | Soybean oil, phospholipid emulsion | Mesh Term | Adjuvants, Anesthesia | Mesh Term | Anti-Arrhythmia Agents | Mesh Term | Bronchodilator Agents | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Asthmatic Agents | Mesh Term | Respiratory System Agents | Mesh Term | Mydriatics | Mesh Term | Parasympatholytics | Mesh Term | Muscarinic Antagonists | Mesh Term | Cholinergic Antagonists | Mesh Term | Cholinergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Fat Emulsions, Intravenous | Mesh Term | Parenteral Nutrition Solutions | Mesh Term | Pharmaceutical Solutions |
| Downcase Mesh Term | atropine | Downcase Mesh Term | soybean oil, phospholipid emulsion | Downcase Mesh Term | adjuvants, anesthesia | Downcase Mesh Term | anti-arrhythmia agents | Downcase Mesh Term | bronchodilator agents | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-asthmatic agents | Downcase Mesh Term | respiratory system agents | Downcase Mesh Term | mydriatics | Downcase Mesh Term | parasympatholytics | Downcase Mesh Term | muscarinic antagonists | Downcase Mesh Term | cholinergic antagonists | Downcase Mesh Term | cholinergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | fat emulsions, intravenous | Downcase Mesh Term | parenteral nutrition solutions | Downcase Mesh Term | pharmaceutical solutions |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52253587 |
| Name | Organophosphorus Poisoning |
| Downcase Name | organophosphorus poisoning |
Id Information
| Sequence: | 40218706 |
| Id Source | org_study_id |
| Id Value | AssiutU_HAA_OP_poisoning |
Design Groups
| Sequence: | 55685494 | Sequence: | 55685495 |
| Group Type | Other | Group Type | Experimental |
| Title | Follow up | Title | intralipid 20% adjuvant |
| Description | Follow Up of 30 patients after administration of atropine. | Description | 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. |
Interventions
| Sequence: | 52566421 | Sequence: | 52566422 |
| Intervention Type | Drug | Intervention Type | Drug |
| Name | Intralipid, 20% Intravenous Emulsion | Name | Intravenous Atropine Sulfate |
| 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. 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. | Description | 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. |
Keywords
| Sequence: | 79985410 |
| Name | intralipid, organophosphorus poisoning |
| Downcase Name | intralipid, organophosphorus poisoning |
Design Outcomes
| Sequence: | 177681556 | Sequence: | 177681555 |
| Outcome Type | secondary | Outcome Type | primary |
| Measure | mortality. | Measure | duration in days of hospitalization and ICU stay |
| Time Frame | four days | Time Frame | four days |
| Description | Death among cases under study. | Description | The primary outcome is to study the difference in total days of hospitalization and ICU stay between the study and control groups. |
Browse Conditions
| Sequence: | 193801822 | Sequence: | 193801823 | Sequence: | 193801824 |
| Mesh Term | Poisoning | Mesh Term | Organophosphate Poisoning | Mesh Term | Chemically-Induced Disorders |
| Downcase Mesh Term | poisoning | Downcase Mesh Term | organophosphate poisoning | Downcase Mesh Term | chemically-induced disorders |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48396527 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Amani Hassan Abdel-Wahab |
Overall Officials
| Sequence: | 29330107 |
| Role | Study Director |
| Name | Hamdy A. Youssef, Professor |
| Affiliation | Professor of anesthesia and intensive care, Assiut University |
Central Contacts
| Sequence: | 12028310 |
| Contact Type | primary |
| Name | Ahmad Hashem Sleem |
| Phone | +201002954939 |
| ahmad_hs_87@med.aun.edu.eg | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68260509 | Sequence: | 68260510 | Sequence: | 68260511 |
| Design Group Id | 55685495 | Design Group Id | 55685494 | Design Group Id | 55685495 |
| Intervention Id | 52566421 | Intervention Id | 52566422 | Intervention Id | 52566422 |
Eligibilities
| Sequence: | 30813381 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 60 Years |
| Healthy Volunteers | No |
| 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: 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. |
| Adult | True |
| Child | False |
| Older Adult | False |
Calculated Values
| Sequence: | 254064308 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Maximum Age Num | 60 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 1 |
Designs
| Sequence: | 30559350 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
| Intervention 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. |
Intervention Other Names
| Sequence: | 26711572 | Sequence: | 26711573 |
| Intervention Id | 52566421 | Intervention Id | 52566422 |
| Name | lipofundin 20 | Name | Atropine 1 mg / 1 ml |
Responsible Parties
| Sequence: | 28925747 |
| Responsible Party Type | Sponsor-Investigator |
| Name | Amani Hassan Abdel-Wahab |
| Title | Professor of anesthesia and intensive care |
| Affiliation | Assiut University |