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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.
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:
Clinical assessment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
| |
| L-Carnitine Group | Experimental | The 36 patients will receive conventional supportive care as in the conventional group in addition to IV L-carnitine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Troponin level | Measure Troponin level in blood samples of patients | In follow-up 24 hours after admission |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zahraa K Sobh, MD | Contact | 01020744739 | +2 | zahraa.sobh@alexmed.edu.eg |
| Maha A Ghanem, MD | Contact | 01223374415 | +2 | ghanemmaha63@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22153012 | Background | 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. | |
| 25215155 | 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. |
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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.
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| ID | Term |
|---|---|
| D002249 | Carbon Monoxide Poisoning |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D005739 | Gas Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Parallel Assignment randomized controlled clinical trial (phase II)
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each patient will take a code number and data were analyzed anonymously
| Assessed up to 1 month. |
| 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 |
| 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 |
| 31297480 | 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. |
| 32440337 | 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. |
| 33401984 | 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. |
| D002318 |
| Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |