Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia
Condition: VAP - Ventilator Associated Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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:

        -  Demographic data,

        -  Physiological variables

        -  Simplified Acute Physiology Score II at admission and radiologic score (Weinberg et al.,
           1984).

        -  Antibiotics used, and relevant diagnostic and therapeutic interventions in the ICU.

        -  The Sequential Organ Failure Assessment (SOFA) score and Clinical Pulmonary Infection
           Score (CPIS) were calculated on the day of enrolment (day 1) and then on days 3, 7, and
           14. Patients were monitored daily for evidence of infection.

        -  The duration of mechanical ventilation, length of ICU stay, and length of hospital stay
           were recorded.

        -  The occurrence of myocardial ischemia or infarction was assessed until day 28. Serum
           levels of creatine kinase, ALT, and AST were measured.

      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.
    

Intervention name(s): Simvastatin
Intervention type(s): Drug
Intervention description(s): simvastatin 60 mg tab
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention