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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - All consecutive patients with ischemic stroke who are admitted to Intensive Care Unit(ICU) between 1st March.2012 at 00:00 hours (midnight) and the finish date of 31st March. 2014 at 23:59 hours (11.59 pm). Patients who are already in the ICU prior to 1st March. 2012 at 00:00 hours will not be included in the study. - Duration of mechanical ventilation > 48h through tracheal tube or tracheotomy - Informed consent Exclusion Criteria: - Patients with pneumonia when they are admitted to ICU. - Previous use of statin for cholesterol regulation. - Chronic liver disease or active liver disease. - Increase of CPK (over 3 times the upper limit) during hospitalization. - Malnutrition. - Pregnancy. - Unwilling to continue the therapy during hospitalization. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Shanghai Minhang Central Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Minhang Central Hospital | Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative frequency of ventilator-associated pneumonia | 30 days | Yes | |
Secondary | Mortality | 30 days | Yes | |
Secondary | Ventilation free days | 30 days | Yes | |
Secondary | Antibiotic free days | 30 days | Yes | |
Secondary | Whether the bacteria of multidrug-resistance can be isolated from the sputum culture | We will find whether methicillin-resistant Staphylococcus aureus(MRSA), extended-spectrum beta-lactamase(ESBLs) or Vancomycin-resistant enterococcus (VRE)can be isolated from the sputum culture. | 30 days | Yes |
Secondary | Adverse effects | Creatine kinase of more than three times the upper normal limit or hepatic enzyme dysfunction. | 30 days | Yes |
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