Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01550419|
Recruitment Status : Unknown
Verified February 2013 by Liu Chunyan, Shanghai Minhang Central Hospital.
Recruitment status was: Recruiting
First Posted : March 12, 2012
Last Update Posted : February 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventilator-associated Pneumonia Ischemic Stroke||Drug: Atorvastatin Drug: Placebo||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2014|
|Experimental: Atorvastatin(50 characters)||
Patients will receive 40mg atorvastatin(one tablet) over night via enteral feeding tube or per os during they stay in ICU at most thirty days.
Other Name: Lipitor
|Placebo Comparator: Placebo(50 characters)||
The smell and shape of placebo are the same as atorvastatin
Other Name: No other name
- Cumulative frequency of ventilator-associated pneumonia [ Time Frame: 30 days ]
- Mortality [ Time Frame: 30 days ]
- Ventilation free days [ Time Frame: 30 days ]
- Antibiotic free days [ Time Frame: 30 days ]
- Whether the bacteria of multidrug-resistance can be isolated from the sputum culture [ Time Frame: 30 days ]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.
- Adverse effects [ Time Frame: 30 days ]Creatine kinase of more than three times the upper normal limit or hepatic enzyme dysfunction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550419
|Contact: Liu ChunYan, MDfirstname.lastname@example.org|
|Contact: Yu YueTian, MDemail@example.com|
|Shanghai Minhang Central Hospital||Recruiting|
|Shanghai, China, 201199|
|Contact: Liu Chunyan, MD 862164923400 firstname.lastname@example.org|
|Contact: Yu Yuetian, MD 862164923400 email@example.com|
|Principal Investigator: Liu Chunyan, MD|
|Principal Investigator:||Liu ChunYan, MD||Shanghai Minhang Central Hospital|