A Phase 2 interventional study of L-Carnitine in Carbon Monoxide Poisoning, sponsored by Alexandria University. Status unknown. Per ClinicalTrials.gov, last updated 2022-12-12.
Sponsored by Alexandria University · Phase 2, Interventional, and Treatment
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:
209 studies on the registry are indexed under Poisoning; 26 are open to participants now.
This study's planned enrollment of 72 is close to the median of 72 across 104 interventional studies indexed under Poisoning.
Browse Poisoning studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Troponin level
Measure Troponin level in blood samples of patients
Time frame: In follow-up 24 hours after admission
Duration of hospital stay
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.
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.
Time frame: Assessed up to 1 month.
Development of delayed neurological manifestations
The number of patients who developed impaired memory and or concentration.
Time frame: Assessed up to 3 months following discharge from the hospital
No study locations are listed for this record.
Plan to share: Undecided — 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.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Alexandria University