A Phase 4 interventional study of Simvastatin in VAP - Ventilator Associated Pneumonia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 29 Years to 71 Years. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Ain Shams University · Phase 4, Interventional, and Prevention
Statins with their powerful anti-inflammatory, immunomodulatory, and antioxidant properties make them candidate members to be used in the management of sepsis and different types of infections including pneumonia.
This study aims to determine whether adjunctive statin therapy decreased day- 28 mortality among ICU patients with ventilator-associated pneumonia (VAP) \& number of ventilator-free days (after successful weaning) between day 1 and both day 28.
This prospective randomized control-controlled triple blind study was conducted on above 18 years who had received mechanical ventilation in the ICU for at least 2 days.
All included cases were subjected to:
Patients were randomly allocated to simvastatin (60 mg) or control given via a nasogastric tube or orally from study inclusion to ICU discharge, death, or day 28, whichever occurred first. Simvastatin or control were started on the same day as antibiotic therapy for suspected VAP. The simvastatin dosage was halved in patients with renal failure (creatinine clearance \<30 mL/min). A computer-generated random- number table was prepared by statisticians to assign patients in blocks of 4 to receive either simvastatin or control.
Block size was unknown to the investigators, who was enrolled the patients and then called the statistics department to obtain the randomization and treatment numbers after checking the inclusion and non-inclusion criteria Outcome The primary outcome was the day-28 mortality rate. Secondary outcomes were ICU mortality rates; number of days outside the ICU between day 1 and day 28; and number of ventilator-free days (after successful weaning) between day 1 and both day 28.
Successful weaning was defined as spontaneous breathing for at least 48 hours after disconnection of the ventilator.
2,045 studies on the registry are indexed under Pneumonia; 284 are open to participants now.
This study's enrollment of 161 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
o Statin therapy at intubation
68 patients who had a ventilator associated pneumonia received simvastatin
Drug: Simvastatin
68 patients who had a ventilator associated pneumonia not received simvastatin
simvastatin 60 mg tab
The primary outcome was the day-28 mortality rate.
asses effect of statin on mortality in ventilator associated pneumonia patient
Time frame: 28 day
ICU mortality rates
rate of mortality of patients with ventilator associated pneumonia between simvastatin group and control group in intensive care unit
Time frame: between day 1 and day 28
number of days outside the ICU between day 1 and day 28
the number of days patients who have improved spent outside the icu between day 1 and day 28
Time frame: between day 1 and day 28
number of ventilator-free days (after successful weaning) between day 1 and both day 28.
number of days patient of the two group spent without ventilator in the intensive care unit between day 1 and day 28 after successful weaning. Successful weaning was defined as spontaneous breathing for at least 48 hours after disconnection of the ventilator.
Time frame: between day 1 and day 28
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Ain Shams University