Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke
Primary Purpose
Ventilator-associated Pneumonia, Ischemic Stroke
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator-associated Pneumonia focused on measuring Ventilator-associated pneumonia, Ischemic stroke, Atorvastatin, Morbidity, Mortality
Eligibility 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.
Sites / Locations
- Shanghai Minhang Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atorvastatin(50 characters)
Placebo(50 characters)
Arm Description
Outcomes
Primary Outcome Measures
Cumulative frequency of ventilator-associated pneumonia
Secondary Outcome Measures
Mortality
Ventilation free days
Antibiotic free days
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.
Adverse effects
Creatine kinase of more than three times the upper normal limit or hepatic enzyme dysfunction.
Full Information
NCT ID
NCT01550419
First Posted
March 2, 2012
Last Updated
February 24, 2013
Sponsor
Shanghai Minhang Central Hospital
Collaborators
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01550419
Brief Title
Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke
Official Title
Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Minhang Central Hospital
Collaborators
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Pneumonia, Ischemic Stroke
Keywords
Ventilator-associated pneumonia, Ischemic stroke, Atorvastatin, Morbidity, Mortality
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin(50 characters)
Arm Type
Experimental
Arm Title
Placebo(50 characters)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
No other name
Intervention Description
The smell and shape of placebo are the same as atorvastatin
Primary Outcome Measure Information:
Title
Cumulative frequency of ventilator-associated pneumonia
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
30 days
Title
Ventilation free days
Time Frame
30 days
Title
Antibiotic free days
Time Frame
30 days
Title
Whether the bacteria of multidrug-resistance can be isolated from the sputum culture
Description
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.
Time Frame
30 days
Title
Adverse effects
Description
Creatine kinase of more than three times the upper normal limit or hepatic enzyme dysfunction.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu ChunYan, MD
Phone
021-64923400
Email
doctorlcy@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu YueTian, MD
Phone
021-64923400
Email
fishyyt@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu ChunYan, MD
Organizational Affiliation
Shanghai Minhang Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Minhang Central Hospital
City
Shanghai
ZIP/Postal Code
201199
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Chunyan, MD
Phone
862164923400
Email
doctorlcy@sina.com
First Name & Middle Initial & Last Name & Degree
Yu Yuetian, MD
Phone
862164923400
Email
fishyyt@sina.com
First Name & Middle Initial & Last Name & Degree
Liu Chunyan, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke
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