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

NCT05647707 | Unknown Phase 2 DMC

• 1 other identifier: 0304888
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carbon Monoxide Poisoning

Keywords

Carbon Monoxide Poisoning; Cardiotoxicity; Troponin; L-Carnitine; Outcome

Outcome Measures

Primary Outcomes (1)

• Troponin level

  Measure Troponin level in blood samples of patients

  In follow-up 24 hours after admission

Secondary Outcomes (3)

• Duration of hospital stay

  Assessed up to 1 month.

• The frequency of ICU admission

  Assessed up to 1 month.

• Development of delayed neurological manifestations

  Assessed up to 3 months following discharge from the hospital

Study Arms (2)

Conventional Group

NO INTERVENTION

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.

L-Carnitine Group

EXPERIMENTAL

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

Dietary Supplement: L-Carnitine

Interventions

L-Carnitine DIETARY_SUPPLEMENT

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.

L-Carnitine Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The current clinical trials will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score.

You may not qualify if:

• When the diagnosis of acute carbon monoxide poisoning is unconfirmed.
• Patients with advanced cardiac and neurological diseases.

Sponsors & Collaborators

• Alexandria University: lead

Related Publications (5)

• 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.

  PMID: 22153012 BACKGROUND

• 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.

  PMID: 25215155 BACKGROUND

• 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.

  PMID: 31297480 BACKGROUND

• 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.

  PMID: 32440337 BACKGROUND

• 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.

  PMID: 33401984 BACKGROUND

MeSH Terms

Conditions

Carbon Monoxide Poisoning; Cardiotoxicity

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Zahraa K Sobh, MD

  Associate Professor of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, Egypt

  PRINCIPAL INVESTIGATOR

• Maha A Ghanem, MD

  Professor of Forensic Medicine and Clinical Toxicology. Head of department of Forensic Medicine and Clinical Toxicology. Chairperson of ethics committee Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Heidi A Elsobky, MS

  Assistant Lecturer of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, Egypt

  STUDY DIRECTOR

• Farah S Habib, Bachelor

  Demonstrator of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, Egypt

  STUDY DIRECTOR

• Fatma Elgazzar, MD

  Professor of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Tanta University, Alexandria, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahraa K Sobh, MD

CONTACT

01020744739; zahraa.sobh@alexmed.edu.eg

Maha A Ghanem, MD

CONTACT

01223374415; ghanemmaha63@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: each patient will take a code number and data were analyzed anonymously
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Forensic Medicine and Clinical Toxicology

Model Details: Parallel Assignment randomized controlled clinical trial (phase II)

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 12, 2022
• Study Start: December 15, 2022
• Primary Completion: April 15, 2023
• Study Completion: August 1, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-12