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

NCT ID: NCT01550419

Last Updated: 2013-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-02-28

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.

Conditions

Ventilator-associated Pneumonia; Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Atorvastatin(50 characters)

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

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.

Placebo(50 characters)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The smell and shape of placebo are the same as atorvastatin

Interventions

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.

Intervention Type: DRUG

Placebo

The smell and shape of placebo are the same as atorvastatin

Intervention Type: DRUG

Other Intervention Names

Lipitor; No other name

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai Minhang Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Chunyan

Department of Intensive Care Unit, Minhang Central Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liu ChunYan, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Minhang Central Hospital

Locations

Shanghai Minhang Central Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Liu ChunYan, MD

Role: CONTACT

doctorlcy@sina.com

021-64923400

Yu YueTian, MD

Role: CONTACT

fishyyt@sina.com

021-64923400

Facility Contacts

Liu Chunyan, MD

Role: primary

doctorlcy@sina.com

862164923400

Yu Yuetian, MD

Role: backup

fishyyt@sina.com

862164923400

Other Identifiers

MHC Hospital 01

Identifier Type: -

Identifier Source: org_study_id