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Effect of Montelukast Versus Co Enzyme in Sepsis

NCT05293132 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-07-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Montelukast Sodium 10 mg

Film coated tablets containing 10 mg montelukast

DRUG

Co-Enzyme Q10

Capsules contain 210 mg Co-Enzyme Q10

DRUG

Standard Treatment

Standard sepsis treatment includes fluid resuscitation, early administration of intravenous broad spectrum antibiotic (ceftriaxone 2gm/24 hour or meropenem 1g/8 hours, linezolid 600/12hours) till obtaining the microbiological culture to narrow the coverage, paracetamol intravenous antipyretic (paracetamol 1gm/8 hours) till no fever and temperature less than 380c, and prophylactic anticoagulant low molecular weight heparin (enoxaparin 40/24 hours), prophylactic stress ulcer (pantoprazole 40mg/24hours)

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Salwa om Amin, PHD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293132 on ClinicalTrials.gov