NCT05230472

Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 29 Years – 71 Years
• Healthy volunteers: Not accepted

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.

Conditions

• VAP - Ventilator Associated Pneumonia

Interventions

Type	Name	Description
DRUG	Simvastatin	simvastatin 60 mg tab

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-20
• Completion: 2022-02-01
• First posted: 2022-02-09
• Last updated: 2022-02-09

Locations

1 site across 1 country: Egypt