Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413589
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-04-18
Brief Title:
Efficacy of SMOF Lipid in the Management of Acute Poisoning With Clozapine
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Efficacy of SMOF Lipid in the Management of Acute Poisoning With Clozapine Secondary IDs
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the current study was to evaluate whether SMOF lipid administration could be used as an adjuvant therapy to treat acute moderate-to-severe clozapine poisoning
Detailed Description:
Antipsychotics a class of drugs primarily used to treat schizophrenia and various mood disorders including bipolar disorder encompass a medication like clozapine Clozapine stands out among antipsychotics due to its lower incidence of extrapyramidal symptoms such as tardive dyskinesia and its effectiveness in addressing negative symptoms of schizophrenia
Recent data from the American Association of Poison Control Centers AAPCC highlight sedativeshypnoticsantipsychotics as among the top five frequently encountered xenobiotics in human exposure cases This class of drugs has seen a notable uptick in incidence over the past 18 years In Egypt studies from institutions like Tanta University Poison Control Centre TUPCC and the National Poisoning Center in Cairo have identified acute clozapine poisoning as a common occurrence within cases of pharmaceutical drug poisonings affecting the central nervous system
Clozapine toxicity manifests across multiple organ systems with the central nervous system CNS and cardiovascular system CVS being most significantly impacted Common symptoms include pronounced sedation confusion delirium tachycardia and mild hypotension
Because there is no definitive antidote for clozapine poisoning poison control centres recommend supportive therapy based on the patients clinical condition and multiple-dose activated charcoal MDAC as a specific intervention for enhanced elimination Nevertheless the elimination of the drug from the body can be prolonged
The scarcity of physiological antidotes for acute poisonings encourages toxicologists to supplement standard supportive treatment protocols with promising agents that tend to improve morbidity and mortality
In this context intravenous lipid emulsions ILE are mainly used as a source of energy and essential fatty acids in patients requiring parenteral nutrition Apart from their nutritional value lipid emulsion therapy is becoming increasingly popular in critical care settings as a treatment for toxicity with lipophilic agents particularly when the standard remedies are ineffective
Following the encouraging outcomes of using ILEs for the treatment of local anaesthetic systemic toxicity subsequent studies reported the therapeutic effect of ILEs in acute poisonings with other xenobiotics However the evidence for the potential effectiveness of ILE in clinical toxicology consists mainly of case reports and experimental studies
ILE may be suitable for the treatment of clozapine toxicity due to its lipid solubility
SMOF 20 a blend of soybean oil medium-chain triglycerides olive oil and fish oil is a new lipid emulsion product that has shown better therapeutic results regarding parentral nutrition when compared with traditional ones such as Intralipid 20 It has been associated with decreased oxidative injury improved liver function and increased antioxidant activity
Recent data from the American Association of Poison Control Centers AAPCC highlight sedativeshypnoticsantipsychotics as among the top five frequently encountered xenobiotics in human exposure cases This class of drugs has seen a notable uptick in incidence over the past 18 years In Egypt studies from institutions like Tanta University Poison Control Centre TUPCC and the National Poisoning Center in Cairo have identified acute clozapine poisoning as a common occurrence within cases of pharmaceutical drug poisonings affecting the central nervous system
Clozapine toxicity manifests across multiple organ systems with the central nervous system CNS and cardiovascular system CVS being most significantly impacted Common symptoms include pronounced sedation confusion delirium tachycardia and mild hypotension
Because there is no definitive antidote for clozapine poisoning poison control centres recommend supportive therapy based on the patients clinical condition and multiple-dose activated charcoal MDAC as a specific intervention for enhanced elimination Nevertheless the elimination of the drug from the body can be prolonged
The scarcity of physiological antidotes for acute poisonings encourages toxicologists to supplement standard supportive treatment protocols with promising agents that tend to improve morbidity and mortality
In this context intravenous lipid emulsions ILE are mainly used as a source of energy and essential fatty acids in patients requiring parenteral nutrition Apart from their nutritional value lipid emulsion therapy is becoming increasingly popular in critical care settings as a treatment for toxicity with lipophilic agents particularly when the standard remedies are ineffective
Following the encouraging outcomes of using ILEs for the treatment of local anaesthetic systemic toxicity subsequent studies reported the therapeutic effect of ILEs in acute poisonings with other xenobiotics However the evidence for the potential effectiveness of ILE in clinical toxicology consists mainly of case reports and experimental studies
ILE may be suitable for the treatment of clozapine toxicity due to its lipid solubility
SMOF 20 a blend of soybean oil medium-chain triglycerides olive oil and fish oil is a new lipid emulsion product that has shown better therapeutic results regarding parentral nutrition when compared with traditional ones such as Intralipid 20 It has been associated with decreased oxidative injury improved liver function and increased antioxidant activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None