search
Back to results

The Efficacy of L-Carnitine in the Management of Acute Carbon Monoxide Poisoning

Primary Purpose

Carbon Monoxide Poisoning

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
L-Carnitine
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carbon Monoxide Poisoning focused on measuring Carbon Monoxide Poisoning, Cardiotoxicity, Troponin, L-Carnitine, Outcome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The current clinical trials will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score. Exclusion Criteria: When the diagnosis of acute carbon monoxide poisoning is unconfirmed. Patients with advanced cardiac and neurological diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Conventional Group

    L-Carnitine Group

    Arm Description

    This group will comprise 36 patients who will receive conventional supportive treatment for the management of acute CO poisoning that include the following: Airway: maintaining clear patent airways. Breathing: High-flow normobaric oxygen (NBO) Hyperbaric oxygen (HBO) (if indicated). Mechanical ventilation ( if required). Circulation: intravenous fluids, and treatment of arrhythmias according to ECG abnormalities.

    The 36 patients will receive conventional supportive care as in the conventional group in addition to IV L-carnitine.

    Outcomes

    Primary Outcome Measures

    Troponin level
    Measure Troponin level in blood samples of patients

    Secondary Outcome Measures

    Duration of hospital stay
    Time passed from the date of admission to the documented date of discharge or death, whichever came first
    The frequency of ICU admission
    The number of patients admitted to ICU from the time of admission till the documented date of discharge or death, whichever came first. Patients who developed serious cardiovascular or neurological manifestations or need mechanical ventilation are indicated for ICU admission.
    Development of delayed neurological manifestations
    The number of patients who developed impaired memory and or concentration.

    Full Information

    First Posted
    November 27, 2022
    Last Updated
    December 8, 2022
    Sponsor
    Alexandria University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05647707
    Brief Title
    The Efficacy of L-Carnitine in the Management of Acute Carbon Monoxide Poisoning
    Official Title
    The Efficacy of L-Carnitine in the Management of Acute Carbon Monoxide Poisoning
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 15, 2022 (Anticipated)
    Primary Completion Date
    April 15, 2023 (Anticipated)
    Study Completion Date
    August 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Alexandria University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Carbon monoxide (CO) poisoning results in high morbidity and mortality worldwide. CO is described as a "silent killer" because CO is colorless, odorless, and tasteless but highly toxic. The diagnosis of acute CO poisoning depends on the history of exposure to a source of fire in a closed space along with the clinical and laboratory findings. The pathophysiology of CO poisoning is not fully understood; however, it is proved that CO induces hypoxia by forming carboxyhemoglobin (COHb) and shifting the oxygen dissociation curve to the left. The molecular mechanisms of CO poisoning include oxidative injury through the generation of free radicals. In addition, oxygen therapy might enhance the reactive oxygen species (ROS) production and result in reperfusion injury. Free radicals could induce a serious impact on vital organs, including the heart, and brain. L-Carnitine is an endogenous mitochondrial constituent that contributes to normal mitochondrial activities. L-Carnitine is an antioxidant with potent ROS scavenging ability. ROS-mediated pathology of CO suggests that antioxidants are potentially useful agents in the alleviation of CO toxicity. Thus, the current study will investigate the therapeutic efficacy of L-Carnitine in improving the prognosis of acute CO poisoning. The current clinical trial will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score.
    Detailed Description
    A randomized clinical trial (phase II) will be conducted at Alexandria Main University Hospital. The total required sample size is 72. The sample size was calculated by G power 3.1.9.4 software program depending on the primary outcome. According to these assumptions: Effect size, defined as the difference between group 1 and group 2 in the mean troponin levels at 24 hr, was calculated according to Sun et al. (2011) and was 0.657, alpha error =0.05, power of 80%, allocation ratio 1:1. A 20% expected attrition was added to the sample size to account for loss to follow-up. So, the final sample size was 72; 36 patients per group. All patients will be subject to the following: History taking: Personal data: age, and sex. Exposure-related data: circumstances of exposure, and time till hospitalization. Past medical history. Clinical assessment: Glasgow coma scale, vital signs, and general examination. Laboratory investigations: arterial blood gases (ABG), Carboxy hemoglobin level (COHb), and cardiac enzymes (CPK, CK-MB, Troponin). Electrocardiogram (ECG).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carbon Monoxide Poisoning
    Keywords
    Carbon Monoxide Poisoning, Cardiotoxicity, Troponin, L-Carnitine, Outcome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment randomized controlled clinical trial (phase II)
    Masking
    Outcomes Assessor
    Masking Description
    each patient will take a code number and data were analyzed anonymously
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional Group
    Arm Type
    No Intervention
    Arm Description
    This group will comprise 36 patients who will receive conventional supportive treatment for the management of acute CO poisoning that include the following: Airway: maintaining clear patent airways. Breathing: High-flow normobaric oxygen (NBO) Hyperbaric oxygen (HBO) (if indicated). Mechanical ventilation ( if required). Circulation: intravenous fluids, and treatment of arrhythmias according to ECG abnormalities.
    Arm Title
    L-Carnitine Group
    Arm Type
    Experimental
    Arm Description
    The 36 patients will receive conventional supportive care as in the conventional group in addition to IV L-carnitine.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    L-Carnitine
    Intervention Description
    The 36 patients will receive conventional supportive care in addition to IV L-carnitine with a loading dose of 100 mg/kg IV over 30-60 min (maximum 6 g) and the maintenance dose of 50 mg/kg IV every 8 h.
    Primary Outcome Measure Information:
    Title
    Troponin level
    Description
    Measure Troponin level in blood samples of patients
    Time Frame
    In follow-up 24 hours after admission
    Secondary Outcome Measure Information:
    Title
    Duration of hospital stay
    Description
    Time passed from the date of admission to the documented date of discharge or death, whichever came first
    Time Frame
    Assessed up to 1 month.
    Title
    The frequency of ICU admission
    Description
    The number of patients admitted to ICU from the time of admission till the documented date of discharge or death, whichever came first. Patients who developed serious cardiovascular or neurological manifestations or need mechanical ventilation are indicated for ICU admission.
    Time Frame
    Assessed up to 1 month.
    Title
    Development of delayed neurological manifestations
    Description
    The number of patients who developed impaired memory and or concentration.
    Time Frame
    Assessed up to 3 months following discharge from the hospital

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The current clinical trials will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score. Exclusion Criteria: When the diagnosis of acute carbon monoxide poisoning is unconfirmed. Patients with advanced cardiac and neurological diseases.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zahraa K Sobh, MD
    Phone
    01020744739
    Ext
    +2
    Email
    zahraa.sobh@alexmed.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maha A Ghanem, MD
    Phone
    01223374415
    Ext
    +2
    Email
    ghanemmaha63@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zahraa K Sobh, MD
    Organizational Affiliation
    Associate Professor of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, Egypt
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Maha A Ghanem, MD
    Organizational Affiliation
    Professor of Forensic Medicine and Clinical Toxicology. Head of department of Forensic Medicine and Clinical Toxicology. Chairperson of ethics committee Faculty of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Heidi A Elsobky, MS
    Organizational Affiliation
    Assistant Lecturer of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, Egypt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Farah S Habib, Bachelor
    Organizational Affiliation
    Demonstrator of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, Egypt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Fatma Elgazzar, MD
    Organizational Affiliation
    Professor of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Tanta University, Alexandria, Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The confidentiality of the personal data of participants will be maintained. The current study will be published in an academic journal, then, the published data could be accessed and used for any purpose.
    Citations:
    PubMed Identifier
    22153012
    Citation
    Sun ZJ, Yang CB, Wang H, Li Y. [The impact of L-carnitine administration on the serum level of myocardium injury markers in patients with acute carbon monoxide poisoning]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2011 Dec;23(12):739-42. Chinese.
    Results Reference
    background
    PubMed Identifier
    25215155
    Citation
    Zengin S, A B, Karta S, Can B, Orkmez M, Taskin A, Lok U, Gulen B, Yildirim C, Taysi S. An assessment of antioxidant status in patients with carbon monoxide poisoning. World J Emerg Med. 2014;5(2):91-5. doi: 10.5847/wjem.j.issn.1920-8642.2014.02.002.
    Results Reference
    background
    PubMed Identifier
    31297480
    Citation
    Yildiz MN, Eroglu SE, Ozen C, Yildiz HA, Sektioglu BK, Alkan C. Analysis of the effects of COHb, lactate, and troponin levels on the clinical process and outcome in patients who were admitted to the emergency service due to carbon monoxide poisoning. North Clin Istanb. 2019 May 29;6(2):141-145. doi: 10.14744/nci.2018.88709. eCollection 2019.
    Results Reference
    background
    PubMed Identifier
    32440337
    Citation
    Sherif NA, El-Banna AS, ElBourini MM, Khalil NO. Efficacy of L-carnitine and propranolol in the management of acute theophylline toxicity. Toxicol Res (Camb). 2020 Mar 11;9(1):45-54. doi: 10.1093/toxres/tfaa002. eCollection 2020 Feb.
    Results Reference
    background
    PubMed Identifier
    33401984
    Citation
    Elgazzar FM, Elgohary MS, Basiouny SM, Lashin HI. Intravenous lipid emulsion as an adjuvant therapy of acute clozapine poisoning. Hum Exp Toxicol. 2021 Jul;40(7):1053-1063. doi: 10.1177/0960327120983873. Epub 2021 Jan 5.
    Results Reference
    background

    Learn more about this trial

    The Efficacy of L-Carnitine in the Management of Acute Carbon Monoxide Poisoning

    We'll reach out to this number within 24 hrs