Efficacy of SMOF Lipid in the Management of Acute Poisoning With Carbamazepine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS)
研究概览
简要总结
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.
详细描述
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 2,562 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 patient's 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients were enrolled in the study in accordance with the following:
- •Gender and age: adult symptomatic males and females.
- •Patients were admitted within 12 hours of exposure to the poison.
- •Patients received no prior treatment before admission.
- •Patients with moderate-to-severe carbamazepine poisoning according to the Poisoning Severity Score (PSS)
- •Patients classified as high-risk (HR) with anti-depressant overdose risk assessment (ADORA) criteria.
排除标准
- •Patients will be excluded if they have any of the following conditions:
- •pregnant and lactating women.
- •Patients with major medical conditions (e.g. diabetes mellitus), cardiovascular disease, renal, or hepatic failure).
- •Patients suffering from hyperlipidemia.
- •Malignancy.
- •Co-ingestion.
研究组 & 干预措施
control group
The first group constitutes the control group that was administered the standard treatment protocol for carbamazepine toxicity.
干预措施: Standard treatment for carbamazepine toxicity (Other)
SMOF lipid treated group
The second group received the SMOF lipid infusion in addition to the standard protocol.
干预措施: SMOF lipid 20% (Drug)
结局指标
主要结局
Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS)
时间窗: participants were monitored within 24 hours from admission to the hospital
This study evaluates the efficacy of SMOF lipid 20% in improving conscious levels among participants with acute carbamazepine poisoning within 24 hours. Conscious level improvement is assessed using the Glasgow Coma Scale (GCS), a widely recognised tool for neurological assessment. The GCS measures eye opening, verbal response, and motor response, with higher scores indicating better conscious levels. The study aims to determine the extent of improvement in GCS scores following SMOF lipid administration, providing valuable insights into its effectiveness in enhancing neurological function.
次要结局
- Assessment of Intubation Requirement Using GCS and APACHE(participants were assessed within 24 hours from admission to the hospital)
- Length of Intensive Care Unit (ICU) Stay(Participants will be monitored throughout their hospitalisation period, and the length of their ICU stay will be recorded from date of randomization until the date of last documented progression up to one month)
- length of hospital stay(Participants will be monitored throughout their hospitalisation period, and the length of their hospital stay will be recorded from date of randomization until the date of last documented progression up to one month)