Trial · NCT05293132
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| Secondary | Serum MDA level | Starting from the randomization date, and on day 7 | An oxidative stress marker |
| Secondary | Temperature | Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | Temperature will be recorded for septic patients |
| Secondary | Blood pressure | Starting from the randomization date till patient ICU discharge or death from any cause, which comes first, assessed up to 30 days. | Both systolic and diastolic blood pressures will be monitored and recorded for septic patients |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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