drugset / Trial / NCT05293132
Effect of Montelukast Versus Co Enzyme in Sepsis
RandomizedParallel-groupOpen-labelTreatment
Summary
Sepsis is a leading cause of morbidity and mortality in intensive care units. Sepsis is a life-threatening organ dysfunction linked to a dysregulated host response to infection. It leads to overwhelming of systemic inflammation causing release of proinflammatory cytokines, which trigger overproduction of reactive oxygen species. Several animal studies with sepsis proved the effectiveness of montelukast and coenzyme Q10 as anti-inflammatory and antioxidants in preventing end organ damage, deterioration, and reducing mortality. Therefore, a clinical trial will be carried out to compare the efficacy and safety of montelukast versus co enzyme Q10 on the clinical outcome in patients with sepsis.
Timeline
- Start
- 2022-02-01
- Primary completion
- 2023-06-01
- Completion
- 2023-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Coenzyme Q10 | Other / unclassified | 210 mg | — |
| Subject | Montelukast | Other / unclassified | 10 mg | Oral |
| Background | Acetaminophen | Small molecule | 1 g | Intravenous |
| Background | Ceftriaxone | Other / unclassified | 2 g | Intravenous |
| Background | Enoxaparin sodium | Other / unclassified | 40 mg | — |
| Background | Linezolid | Other / unclassified | 600 mg | Intravenous |
| Background | Meropenem | Small molecule | 1 g | Intravenous |
| Background | Pantoprazole | Other / unclassified | 40 mg | — |