Acute Poisoning Clinical Trial
Official title:
Efficacy of SMOF Lipid in the Management of Acute Poisoning With Carbamazepine
Verified date | March 2024 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 54 Years |
Eligibility | Inclusion Criteria: The patients were enrolled in the study in accordance with the following: 1. Gender and age: adult symptomatic males and females. 2. Patients were admitted within 12 hours of exposure to the poison. 3. Patients received no prior treatment before admission. 4. Patients with moderate-to-severe carbamazepine poisoning according to the Poisoning Severity Score (PSS) 5. Patients classified as high-risk (HR) with anti-depressant overdose risk assessment (ADORA) criteria. Exclusion Criteria: Patients will be excluded if they have any of the following conditions: 1. pregnant and lactating women. 2. Patients with major medical conditions (e.g. diabetes mellitus), cardiovascular disease, renal, or hepatic failure). 3. Patients suffering from hyperlipidemia. 4. Malignancy. 5. Co-ingestion. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Jaffal K, Chevillard L, Megarbane B. Lipid Emulsion to Treat Acute Poisonings: Mechanisms of Action, Indications, and Controversies. Pharmaceutics. 2023 May 3;15(5):1396. doi: 10.3390/pharmaceutics15051396. — View Citation
Karaman K, Turkdogan KA, Deniz AT, Canakci SE. Which is the best in carbamazepine overdose? Clin Case Rep. 2017 Aug 22;5(10):1612-1615. doi: 10.1002/ccr3.1118. eCollection 2017 Oct. — View Citation
Taftachi F, Sanaei-Zadeh H, Sepehrian B, Zamani N. Lipid emulsion improves Glasgow coma scale and decreases blood glucose level in the setting of acute non-local anesthetic drug poisoning--a randomized controlled trial. Eur Rev Med Pharmacol Sci. 2012 Mar;16 Suppl 1:38-42. — View Citation
Zyoud SH, Waring WS, Al-Jabi SW, Sweileh WM, Rahhal B, Awang R. Intravenous Lipid Emulsion as an Antidote for the Treatment of Acute Poisoning: A Bibliometric Analysis of Human and Animal Studies. Basic Clin Pharmacol Toxicol. 2016 Nov;119(5):512-519. doi: 10.1111/bcpt.12609. Epub 2016 May 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS) | 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. | participants were monitored within 24 hours from admission to the hospital | |
Secondary | Assessment of Intubation Requirement Using GCS and APACHE | This study investigates the requirement for intubation and mechanical ventilation among participants with acute carbamazepine poisoning using multiple clinical assessment tools, including the Glasgow Coma Scale (GCS) and Acute Physiology and Chronic Health Evaluation (APACHE). The GCS evaluates the level of consciousness based on eye opening, verbal response, and motor response, with lower scores indicating a higher likelihood of intubation and mechanical ventilation. The APACHE score assesses the severity of illness and predicts the need for respiratory support, with higher scores indicating an increased risk of respiratory failure and the requirement for intervention. | participants were assessed within 24 hours from admission to the hospital | |
Secondary | Length of Intensive Care Unit (ICU) Stay | This study evaluates the length of stay in the Intensive Care Unit (ICU) among participants with acute carbamazepine poisoning. The length of the ICU stay is defined as the duration from the time of admission to the ICU to discharge from the ICU in days. Participants will be monitored throughout their hospitalisation period, and the length of their ICU stay will be recorded. The study aims to assess the impact of SMOF lipid administration on the duration of ICU stays, providing insights into its effectiveness in optimising resource utilisation and patient management. Understanding the factors influencing the length of the ICU stay may contribute to improved healthcare delivery and patient outcomes in acute carbamazepine poisoning. | 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 | |
Secondary | length of hospital stay | This study evaluates the length of stay in the hospital among participants with acute carbamazepine poisoning. The length of stay is defined as the duration from the time of admission to the hospital to discharge from the hospital in days. Participants will be monitored throughout their hospitalisation period, and the length of their hospital stay will be recorded. The study aims to assess the impact of SMOF lipid administration on the duration of hospital stays, providing insights into its effectiveness in optimising resource utilisation and patient management. Understanding the factors influencing length of stay may contribute to improved healthcare delivery and patient outcomes in acute carbamazepine poisoning. | 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 |
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