Effect of Montelukast Versus Co Enzyme in Sepsis

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Coenzyme Q10; Montelukast; Ubiquinone

Criteria

Inclusion Criteria:

Age >18 years old.

• Males and females

• Confirmed diagnosis of sepsis according to the third sepsis definition which include documented or suspected infection, plus an acute change in total SOFA score ≥ 2 points

Exclusion Criteria:

• Pregnancy

• A severe moribund state

• An anticipated ICU stay of less than 24 hours.

• Patients with a history of hypersensitivity to montelukast or co enzyme Q10.

• Patients with systemic eosinophilia in the blood or vasculitis.

• Patients with neuropsychiatric diseases as hallucinations, depression or suicidal thoughts that put the patient at risk when participating in the study.

• Unable to receive enteral medications.