Trial · NCT05293132
Effect of Montelukast Versus Co Enzyme in Sepsis
NCT05293132, Phase 2, Phase 3, Completed, Ain Shams University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Montelukast Versus Co Enzyme in Sepsis. Trials, record NCT05293132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05293132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Montelukast Versus Co Enzyme in Sepsis
- NCT number
- NCT05293132
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 90 participants, actual
- Lead sponsor
- Ain Shams University
- Conditions
- Sepsis
- Interventions
- Montelukast Sodium 10 mg, Co-Enzyme Q10, Standard Treatment
- First posted
- 2022-03-24
- Last updated
- 2023-07-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Twenty-eight-day mortality | Starting from the randomization date up to 28 days | All patients will be followed up in the ICU and by phone calls after discharge. The 28-day mortality rate will be evaluated and recorded. |
| Secondary | Sequential organ failure assessment score | Starting from the randomization date,on day 3, on day7, and then every 3 days till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | It measures sepsis related end organ damage. It includes serum creatinine level as the renal component, total bilirubin level as the hepatic component, Glasgow coma score as the central nervous system component, mean arterial pressure, PaO2, and platelet count. The minimum value is zero, and the maximum value is 24, the higher the score, the worse the outcome, as the maximum value means the expected mortality is more than 90%, and the minimum value means the expected mortality is less than 10% |
| Secondary | C- reactive protein | Starting from the randomization date,on day 3, and on day7 | Marker C- reactive protein will evaluate the state of inflammation in septic patients. |
| Secondary | Heart rate | Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | Heart rate will be monitored and recorded for septic patients |
| Secondary | ICU length of stay | Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | Length of patient stay in the ICU. |
| Secondary | Length of hospital stay | Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | Length of patient stay in the hospital. |
| Secondary | The need for mechanical ventilation The number of patients who will need mechanical ventilation in addition to the duration of ventilation will be recorded | Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | The number of patients who will need mechanical ventilation in addition to the duration of ventilation will be recorded |
| Secondary | The need for vasopressors | Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | The number of patients who will receive vasopressors in addition to the dose and duration of vasopressor use will be recorded. |
| Secondary | The incidence of treatment side effects and the number of their occurrence | Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | Record the incidence of treatment side effects and the number of their occurrence including dermatological reactions, nausea, vomiting or diarrhea, cough or acute bronchitis, headache, gastrointestinal disorders, fatigue, gastrointestinal upset, and heartburn. |
| Secondary | Serum tumor necrosis factor α level | Starting from the randomization date, and on day 7 | An inflammatory marker |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40845766 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05293132
GET https://conductscience.org/api/trials/v1/NCT05293132/registered