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

NCT01550419 | Unknown Early Phase 1 DMC

• 1 other identifier: MHC Hospital 01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-associated Pneumonia; Ischemic Stroke

Keywords

Ventilator-associated pneumonia; Ischemic stroke; Atorvastatin; Morbidity; Mortality

Outcome Measures

Primary Outcomes (1)

• Cumulative frequency of ventilator-associated pneumonia

  30 days

Secondary Outcomes (5)

• Mortality

  30 days

• Ventilation free days

  30 days

• Antibiotic free days

  30 days

• Whether the bacteria of multidrug-resistance can be isolated from the sputum culture

  30 days

• Adverse effects

  30 days

Study Arms (2)

Atorvastatin(50 characters)

EXPERIMENTAL

Drug: Atorvastatin

Placebo(50 characters)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Atorvastatin 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.

Also known as: Lipitor

Atorvastatin(50 characters)

Placebo DRUG

The smell and shape of placebo are the same as atorvastatin

Also known as: No other name

Placebo(50 characters)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Minhang Central Hospital: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Minhang Central Hospital

Shanghai, 201199, China

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Ischemic Stroke

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Liu ChunYan, MD

  Shanghai Minhang Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu ChunYan, MD

CONTACT

021-64923400; doctorlcy@sina.com

Yu YueTian, MD

CONTACT

021-64923400; fishyyt@sina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Intensive Care Unit, Minhang Central Hospital

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 12, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

CN (1)