Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ventilator-associated Pneumonia Ischemic Stroke |
Drug: Atorvastatin Drug: Placebo |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke |
- Cumulative frequency of ventilator-associated pneumonia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Ventilation free days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Antibiotic free days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Whether the bacteria of multidrug-resistance can be isolated from the sputum culture [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Creatine kinase of more than three times the upper normal limit or hepatic enzyme dysfunction.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Contact: Liu ChunYan, MD | 021-64923400 | doctorlcy@sina.com |
| Contact: Yu YueTian, MD | 021-64923400 | fishyyt@sina.com |
| China | |
| Shanghai Minhang Central Hospital | Recruiting |
| Shanghai, China, 201199 | |
| Contact: Liu Chunyan, MD 862164923400 doctorlcy@sina.com | |
| Contact: Yu Yuetian, MD 862164923400 fishyyt@sina.com | |
| Principal Investigator: Liu Chunyan, MD | |
| Principal Investigator: | Liu ChunYan, MD | Shanghai Minhang Central Hospital |
More Information
No publications provided
| Responsible Party: | Liu Chunyan, Department of Intensive Care Unit, Minhang Central Hospital, Shanghai Minhang Central Hospital |
| ClinicalTrials.gov Identifier: | NCT01550419 History of Changes |
| Other Study ID Numbers: | MHC Hospital 01 |
| Study First Received: | March 2, 2012 |
| Last Updated: | February 24, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Shanghai Minhang Central Hospital:
|
Ventilator-associated pneumonia Ischemic stroke Atorvastatin Morbidity Mortality |
Additional relevant MeSH terms:
|
Ischemia Pneumonia Stroke Cerebral Infarction Pneumonia, Ventilator-Associated Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Brain Ischemia Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 17, 2013