Carbon Monoxide PoisoningPhase 2NCT05647707
The Efficacy of L-Carnitine in the Management of Acute Carbon Monoxide Poisoning
A Phase 2 study testing L-Carnitine in people with Carbon Monoxide Poisoning, run by Alexandria University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- L-Carnitine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2022to 1 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The current clinical trials will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score.
Who cannot join
- When the diagnosis of acute carbon monoxide poisoning is unconfirmed.
- Patients with advanced cardiac and neurological diseases.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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).
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- L-Carnitine
- Keywords
- Carbon Monoxide Poisoning, Cardiotoxicity, Troponin, L-Carnitine, Outcome
- Medical subject headings
- Carbon Monoxide Poisoning, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: L-Carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin level
Measure Troponin level in blood samples of patients
Measured: In follow-up 24 hours after admission
Secondary outcomes (3)
Duration of hospital stay
Time passed from the date of admission to the documented date of discharge or death, whichever came first
Measured: 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.
Measured: Assessed up to 1 month.
Development of delayed neurological manifestations
The number of patients who developed impaired memory and or concentration.
Measured: Assessed up to 3 months following discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment randomized controlled clinical trial (phase II)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zahraa khalifa sobh, Alexandria University
- Investigators
- Zahraa K Sobh, MD, Principal investigator, Associate Professor of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, EgyptMaha A Ghanem, MD, Principal investigator, Professor of Forensic Medicine and Clinical Toxicology. Head of department of Forensic Medicine and Clinical Toxicology. Chairperson of ethics committee Faculty of MedicineHeidi A Elsobky, MS, Study director, Assistant Lecturer of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, EgyptFarah S Habib, Bachelor, Study director, Demonstrator of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, EgyptFatma Elgazzar, MD, Principal investigator, Professor of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Tanta University, Alexandria, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647707
- Sponsor's protocol ID
- 0304888
- Status last verified
- Dec 2022
- First submitted
- 27 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 22153012Zengin 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.
PubMed 25215155Yildiz 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.
PubMed 31297480Sherif 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.
PubMed 32440337Elgazzar 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.
PubMed 33401984
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of L-Carnitine in the Management of Acute Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT05647707
- Acronym / sponsor ID
- 0304888
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- Carbon Monoxide Poisoning, Cardiotoxicity, Troponin, L-Carnitine, Outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment randomized controlled clinical trial (phase II)
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: L-CarnitineThe 36 patients will receive conventional supportive care as in the conventional group in addition to IV L-carnitine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The current clinical trials will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score.
Key exclusion criteria (2 listed)
- When the diagnosis of acute carbon monoxide poisoning is unconfirmed.
- Patients with advanced cardiac and neurological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CarnitineThe 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. | Dietary supplement | L-Carnitine Group |
Primary outcome
Troponin level
Time frame: In follow-up 24 hours after admission
Measure Troponin level in blood samples of patients
3 secondary outcomes
Duration of hospital stay
Time frame: Assessed up to 1 month.
The frequency of ICU admission
Time frame: Assessed up to 1 month.
Development of delayed neurological manifestations
Time frame: Assessed up to 3 months following discharge from the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 22153012Sun 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.
- Background: PubMed 25215155Zengin 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.
- Background: PubMed 31297480Yildiz 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.
- Background: PubMed 32440337Sherif 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.
- Background: PubMed 33401984Elgazzar 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahraa K Sobh, MD principal investigator
Associate Professor of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, Egypt
Maha A Ghanem, MD principal investigator
Professor of Forensic Medicine and Clinical Toxicology. Head of department of Forensic Medicine and Clinical Toxicology. Chairperson of ethics committee Faculty of Medicine
Heidi A Elsobky, MS study director
Assistant Lecturer of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Alexandria, Egypt
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-Carnitine in people with Carbon Monoxide Poisoning, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahraa K Sobh, MD (01020744739 ext. +2, zahraa.sobh@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin level (time frame: In follow-up 24 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647707, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.