Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316362
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-05
Brief Title:
Efficacy of SMOF Lipid in the Management of Acute Poisoning With Carbamazepine
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Efficacy of SMOF Lipid in the Management of Acute Poisoning With Carbamazepine
Status:
COMPLETED
Status Verified Date:
2024-03
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 carbamazepine poisoning
Detailed Description:
Among anticonvulsants carbamazepine CBZ is considered one of the most commonly reported poisonings Carbamazepine CBZ was approved for use as a primary anticonvulsant agent following its initial use for trigeminal neuralgia Further indications for the drug included treatment for bipolar disorder resistant schizophrenia and pain syndromes
The wide availability of carbamazepine increases the potential for overdose either accidentally or intentionally The American Association of Poison Control Centres reported 2562 hazardous exposures to CBZ in 2020 In addition CBZ was the most commonly used anti-epileptic drug according to a recent study by the National Centre for Environmental and Clinical Toxicology Research Cairo Egypt
CBZ works by blocking presynaptic voltage-gated sodium channels thereby inhibiting the release of synaptic glutamate and other neurotransmitters
Overdose of CBZ is clinically manifested by nystagmus nausea dysarthria ataxia sedation delirium mydriasis ophthalmoplegia and myoclonus The serious clinical problems resulting from large overdoses of CBZ are cardiotoxicity respiratory depression apnea seizures and coma Mortality from CBZ poisoning is uncommon
Because there is no definitive antidote for carbamazepine 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 In cases of CBZ poisoning ILE was not evaluated using a randomised control trial RCT
ILE may be suitable for the treatment of CBZ toxicity due to its lipid solubility To the best of our knowledge the effect of ILE therapy on acute carbamazepine poisoning has not been studied sufficiently
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
The wide availability of carbamazepine increases the potential for overdose either accidentally or intentionally The American Association of Poison Control Centres reported 2562 hazardous exposures to CBZ in 2020 In addition CBZ was the most commonly used anti-epileptic drug according to a recent study by the National Centre for Environmental and Clinical Toxicology Research Cairo Egypt
CBZ works by blocking presynaptic voltage-gated sodium channels thereby inhibiting the release of synaptic glutamate and other neurotransmitters
Overdose of CBZ is clinically manifested by nystagmus nausea dysarthria ataxia sedation delirium mydriasis ophthalmoplegia and myoclonus The serious clinical problems resulting from large overdoses of CBZ are cardiotoxicity respiratory depression apnea seizures and coma Mortality from CBZ poisoning is uncommon
Because there is no definitive antidote for carbamazepine 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 In cases of CBZ poisoning ILE was not evaluated using a randomised control trial RCT
ILE may be suitable for the treatment of CBZ toxicity due to its lipid solubility To the best of our knowledge the effect of ILE therapy on acute carbamazepine poisoning has not been studied sufficiently
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