Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke

This study is currently recruiting participants.
Verified February 2013 by Shanghai Minhang Central Hospital
Sponsor:
Collaborator:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Liu Chunyan, Shanghai Minhang Central Hospital
ClinicalTrials.gov Identifier:
NCT01550419
First received: March 2, 2012
Last updated: February 24, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Shanghai Minhang Central Hospital:

Primary Outcome Measures:
  • Cumulative frequency of ventilator-associated pneumonia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550419

Contacts
Contact: Liu ChunYan, MD 021-64923400 doctorlcy@sina.com
Contact: Yu YueTian, MD 021-64923400 fishyyt@sina.com

Locations
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         
Sponsors and Collaborators
Shanghai Minhang Central Hospital
Shanghai Jiao Tong University School of Medicine
Investigators
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:
Pneumonia, Ventilator-Associated
Ischemia
Pneumonia
Stroke
Cerebral Infarction
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 April 16, 2014