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

Carbon Monoxide Poisoning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05647707
• Other study ID #: 0304888
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 15, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2022
• Source: Alexandria University
• Contact: Zahraa K Sobh, MD
• Phone: 01020744739
• Email: zahraa.sobh[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. History taking:

• Personal data: age, and sex.

• Exposure-related data: circumstances of exposure, and time till hospitalization.

• Past medical history.

2. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: August 1, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carbon Monoxide Poisoning
• Poisoning

Intervention

Dietary Supplement:
• L-Carnitine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin level	Measure Troponin level in blood samples of patients	In follow-up 24 hours after admission
Secondary	Duration of hospital stay	Time passed from the date of admission to the documented date of discharge or death, whichever came first	Assessed up to 1 month.
Secondary	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.	Assessed up to 1 month.
Secondary	Development of delayed neurological manifestations	The number of patients who developed impaired memory and or concentration.	Assessed up to 3 months following discharge from the hospital