Efficacy of SMOF Lipid in the Management of Acute Poisoning With Carbamazepine

NCT06316362 | Completed Phase 2

• 1 other identifier: SMOF in carbamazepine toxicity
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Poisoning

Keywords

Carbamazepine poisoning; SMOF lipid; lipophilic agents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

control group

OTHER

The first group constitutes the control group that was administered the standard treatment protocol for carbamazepine toxicity.

Other: Standard treatment for carbamazepine toxicity

SMOF lipid treated group

ACTIVE COMPARATOR

The second group received the SMOF lipid infusion in addition to the standard protocol.

Drug: SMOF lipid 20%

Interventions

SMOF lipid 20% DRUG

SMOF 20%; a blend of (soybean oil, medium chain triglycerides, olive and fish oil) is a new lipid emulsion product that was provided as a bolus dose of 1.5ml/kg for one hour, followed by a maintenance dose of 6 ml/kg for a period of four hours to the active comparator group

SMOF lipid treated group

Standard treatment for carbamazepine toxicity OTHER

Hypotension was initially treated with isotonic crystalloid; vasopressors were utilised if intravenous fluids failed to restore the hypotension. This was in the form of norepinephrine with a dose of 0.05 μg/kg/min and titrated till reaching the goal mean arterial pressure (\>65 mmHg). Those experiencing seizures due to CBZ overdose were treated with benzodiazepines (diazepam) at a dose of 10-20 mg. Benzodiazepines are considered allosteric modulators of the gamma-aminobutyric acid channel. MDAC (50 grammes every six hours) was given to all patients in the current study. Those with severe poisoning were given the MDAC after securing the airway with a cuffed endotracheal tube

control group

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, Egypt

Location

Related Publications (4)

• 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.

  PMID: 27098056 BACKGROUND

• 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.

  PMID: 29026556 BACKGROUND

• 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.

  PMID: 37242638 BACKGROUND

• 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.

  PMID: 22582483 BACKGROUND

Study Officials

• Abeer Sheta, professor

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 28, 2023
• Last Updated: October 10, 2024

Record last verified: 2024-03

Locations

EG (1)