Journal of critical care · 2025
The clinical outcome of Montelukast versus co-enzyme Q10 in adult patients with sepsis: A randomized controlled clinical trial.
Клиническое исследование II фазыКлиническое исследование III фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Eladly Ghada Hussein, Amin Salwa Omar Elkhattab, Sabri Nagwa Ali, Shawki May Ahmed
Аннотация
BACKGROUND: Oxidative stress and inflammatory cytokines are involved in sepsis pathogenesis with associated high rate of morbidity and mortality. This study aimed to evaluate the potential benefits of montelukast and co-enzyme Q10 (CoQ10) in septic patients as anti-inflammatory and antioxidant adjunctive therapies.
METHODS: An open label randomized controlled trial was conducted at an intensive care unit (ICU). Ninety adult septic patients were randomized to receive the standard care alone (n = 30, control), or the standard care in addition to either montelukast sodium 10 mg/day (n = 30) or CoQ10 210 mg/day (n = 30). The 28-day mortality was the study primary outcome. Secondary outcomes included the duration of mechanical ventilation (MV) and vasopressor, SOFA score, tumor necrosis factor- α (TNF- α), and malondialdehyde (MDA).
RESULTS: The 28- day mortality rate was 23.3 %, 33.3 %, and 56.7 % in the montelukast, CoQ10, and control with only significant difference being observed between the montelukast and the control groups (p- value = 0.024). The duration of vasopressor was significantly higher in the control group (mean ± SD = 9.8 ± 4.8 days) than the CoQ10 group (mean ± SD = 5.4 ± 2.7 days) and the montelukast group (mean ± SD = 2.9 ± 1.3 days) with p-values <0.001, while the montelukast and CoQ10 groups showed comparable results. The same was observed regarding the duration of MV. Both montelukast and CoQ10 showed significant positive effect on SOFA score, procalcitonin, C-reactive protein (CRP), TNF- α and MDA. Montelukast didn't show any adverse effects. However, 20 % of CoQ10 patients experienced hypotension.
CONCLUSION: Montelukast and CoQ10 were tolerable and showed potential benefits as add on therapies in sepsis management.
TRIAL REGISTRATION: The trial was registered at clinical trial.gov (NCT05293132). https://clinicaltrials.gov/study/NCT05293132?cond=Sepsis&term=Montelukast&rank=1.
METHODS: An open label randomized controlled trial was conducted at an intensive care unit (ICU). Ninety adult septic patients were randomized to receive the standard care alone (n = 30, control), or the standard care in addition to either montelukast sodium 10 mg/day (n = 30) or CoQ10 210 mg/day (n = 30). The 28-day mortality was the study primary outcome. Secondary outcomes included the duration of mechanical ventilation (MV) and vasopressor, SOFA score, tumor necrosis factor- α (TNF- α), and malondialdehyde (MDA).
RESULTS: The 28- day mortality rate was 23.3 %, 33.3 %, and 56.7 % in the montelukast, CoQ10, and control with only significant difference being observed between the montelukast and the control groups (p- value = 0.024). The duration of vasopressor was significantly higher in the control group (mean ± SD = 9.8 ± 4.8 days) than the CoQ10 group (mean ± SD = 5.4 ± 2.7 days) and the montelukast group (mean ± SD = 2.9 ± 1.3 days) with p-values <0.001, while the montelukast and CoQ10 groups showed comparable results. The same was observed regarding the duration of MV. Both montelukast and CoQ10 showed significant positive effect on SOFA score, procalcitonin, C-reactive protein (CRP), TNF- α and MDA. Montelukast didn't show any adverse effects. However, 20 % of CoQ10 patients experienced hypotension.
CONCLUSION: Montelukast and CoQ10 were tolerable and showed potential benefits as add on therapies in sepsis management.
TRIAL REGISTRATION: The trial was registered at clinical trial.gov (NCT05293132). https://clinicaltrials.gov/study/NCT05293132?cond=Sepsis&term=Montelukast&rank=1.