Ischemic Stroke Clinical Trial
Official title:
Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke
Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in
ventilated critically ill patients specially in intensive care unit (ICU). It is associated
with an increased duration of mechanical ventilation, high death rates and increased
healthcare costs in China. However, VAP is preventable and many practices have been
demonstrated to reduce the incidence of this disease, but the morbidity is still so high. So
much more methods of prevention should be needed to reduce the incidence of VAP.
Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) present
anti-inflammatory and immunomodulatory effects besides their ability to regulate cholesterol
composition. So it is hypothesized that early use of statin may prevent some of the
infection disease such as VAP.
Actually, Two studies have showed that statin treatment is associated with reduced risk of
pneumonia. However, the relationship between statins and reduced risk of pneumonia is not
consistent.
After reviewing some of the guidelines,meta analyses and system reviews, the investigator
find that advanced age,immune suppression from disease or medication and specially depressed
level of consciousness are the risk factors of VAP. So the investigator assumes that early
use of statin may give us a favorable outcome in the patients with coma or in the patients
with severe disease (Acute Physiology and Chronic Health Evaluation II score > 15 or Glasgow
coma score < 7).
In addition there is no prospective study to investigate the role of statins in VAP in the
patients with ischemic stroke. The investigator hopes that this study can approve the
relationship between statins and reduced risk of VAP in the patients with ischemic stroke.
And it can improve the processes,outcomes and costs of critical care as well.
This is a one-center, two-arm, randomized, single-blinded, controlled trial. When a patient
with ischemic stroke who needs mechanic ventilation is admitted to ICU,a sealed envelop will
be opened which decide whether the patient is assigned to the placebo arm or the
atorvastatin arm. During they stay in ICU, one tablet of atorvastatin (40mg) or one tablet
of placebo will be administered. Atorvastatin or placebo will be administered through an
enteral feeding tube or administered orally when patients are able to safely take oral
medications.
VAP diagnosis accords with the comprehensive evidence-based clinical practice guidelines for
ventilator-associated pneumonia:Diagnosis and treatment which was published in 2008.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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