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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. 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
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Liu Chunyan, Shanghai Minhang Central Hospital

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Atorvastatin(50 characters) Drug: Atorvastatin
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) Drug: Placebo
The smell and shape of placebo are the same as atorvastatin
Other Name: No other name

Primary Outcome Measures :
  1. Cumulative frequency of ventilator-associated pneumonia [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
  2. Ventilation free days [ Time Frame: 30 days ]
  3. Antibiotic free days [ Time Frame: 30 days ]
  4. 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.

  5. Adverse effects [ Time Frame: 30 days ]
    Creatine kinase of more than three times the upper normal limit or hepatic enzyme dysfunction.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01550419

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Contact: Liu ChunYan, MD 021-64923400
Contact: Yu YueTian, MD 021-64923400

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Shanghai Minhang Central Hospital Recruiting
Shanghai, China, 201199
Contact: Liu Chunyan, MD    862164923400   
Contact: Yu Yuetian, MD    862164923400   
Principal Investigator: Liu Chunyan, MD         
Sponsors and Collaborators
Shanghai Minhang Central Hospital
Shanghai Jiao Tong University School of Medicine
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Principal Investigator: Liu ChunYan, MD Shanghai Minhang Central Hospital

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Responsible Party: Liu Chunyan, Department of Intensive Care Unit, Minhang Central Hospital, Shanghai Minhang Central Hospital Identifier: NCT01550419     History of Changes
Other Study ID Numbers: MHC Hospital 01
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013

Keywords provided by Liu Chunyan, Shanghai Minhang Central Hospital:
Ventilator-associated pneumonia
Ischemic stroke

Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Brain Infarction
Brain Ischemia
Cross Infection
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors