The clinical outcome of Montelukast versus co-enzyme Q10 in adult patients with sepsis: A randomized controlled clinical trial.

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.