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

Plain-language guide to NCT05647707: phase 2 randomized trial of L-Carnitine, 72 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05647707
Phase
phase 2
Status
status unknown
Start
2022-12-15
Completion (planned or actual)
2023-04-15
Participants
72 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Carbon Monoxide Poisoning
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around L-Carnitine.

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.

It had two arms (groups): Conventional Group (no intervention) and L-Carnitine Group (experimental).

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.

The registry classes the interventions as dietary supplement.

More on the Plan

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.

So, the final sample size was 72; 36 patients per group.

Who Took Part

72 planned participants were the target.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The current clinical trials will include patients with moderate and severe acute carbon monoxide poisoning according to Poisoning Severity Score.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: when the diagnosis of acute carbon monoxide poisoning is unconfirmed; patients with advanced cardiac and neurological diseases.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

In this single-blind L-Carnitine study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2022-12-15 with completion listed for 2023-04-15.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Troponin level (time frame: In follow-up 24 hours after admission).

It also tracked 3 secondary outcomes, for example Duration of hospital stay, The frequency of ICU admission and Development of delayed neurological manifestations.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 72 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.

Our Notes on the Compound

L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.